Double-blind, Randomized, Placebo-controlled Phase 3 Study Evaluating Efficacy and Safety of IgPro20 (Subcutaneous Immunoglobulin, HIZENTRA®) in Post-COVID-19 Postural Orthostatic Tachycardia Syndrome (POTS)

This is a prospective, phase 3, multicenter, double-blind, randomized placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics (PK) of repeat doses of IgPro20 in participants with post SARS-CoV-2 infection 2019 postural orthostatic tachycardia syndrome (post-Coronavirus Disease 2019 [COVID-19] POTS [post-COVID-POTS]).

Start Date28 Aug 2024

Sponsor / Collaborator

CSL Behring LLC

NCT05193552

/ RecruitingPhase 4IIT

A Prospective Study of the Utility of Spirometry to Identify and Manage Immunoglobulin Replacement Dosage in Primary Antibody Deficiency in Patients With Potentially Reversible Airway Disease

Although there is evidence in the literature that gammaglobulin replacement therapy can lead to a reduction in the prevalence of pulmonary infection and improved lung function, there is no published study to guide immunologists regarding the use of spirometry in titrating IG therapy to assist in the management of immunodeficiency patients with regards to gammaglobulin replacement therapy.
The investigators propose to study the use of spirometry to identify patients that could potentially benefit from an increase in IGRT. The investigators will identify 22 common variable immune deficiency (CVID) study subjects on stable IGRT replacement therapy equivalent to 0.40 to 0.60 gm/kg per 4 weeks who have evidence of mild to moderate obstruction as assessed by an FEF25-75% between 50% and 80% of predicted. Patients who are on Hizentra will be preferentially recruited. Of these 22, 11 will be identified at random and treated for 6 months at their current dose (control population). The remaining 11 study subjects (treatment group) will have their level of IGRT increased by the equivalent of 0.05 gm/kg in dose per 4 weeks, adjusted for bioavailability as per manufacturer's instructions. On average, rounded up to the nearest gram, this will typically increase their dose of Hizentra by 2 gm per week.

Start Date15 Jan 2024

Sponsor / Collaborator

The University of Alabama at Birmingham

NCT05614128

/ RecruitingNot ApplicableIIT

Validation of Cutaneous Nerve Demyelination in Diagnosis and Treatment of CIDP

The goal of this observational study is to learn about chronic inflammatory demyelinating polyneuropathy. The main question the investigators would like to answer is 1) can skin biopsy identify demyelination better than nerve conduction studies (electrical tests of the nerves)? and 2) how do nerves improve after treatment in CIDP? Participants will be asked to undergo skin biopsy of the finger at baseline and at 3 months and 6 months after treatment with IVIG (which is the FDA approved treatment for CIDP).

Start Date28 Feb 2023

Sponsor / Collaborator

Vanderbilt University Medical Center

[+1]

100 Clinical Results associated with Normal Human Immunoglobulin (CSL Behring)

100 Translational Medicine associated with Normal Human Immunoglobulin (CSL Behring)

100 Patents (Medical) associated with Normal Human Immunoglobulin (CSL Behring)

690

Literatures (Medical) associated with Normal Human Immunoglobulin (CSL Behring)

01 Jan 2025·INTERNATIONAL JOURNAL OF BIOLOGICAL MACROMOLECULES

The interaction of cinchonine and immunoglobulin G and the development of a nanocomplex with improved anti-breast cancer activity

Article

Author: Sun, Jun ; Hou, Yuxin ; Li, Yinyan ; Sun, Minglu ; Li, Qiaobei ; Lou, Zhe ; Wang, Chunyan

In this study we evaluated the interaction of cinchonine (Cin) and immunoglobulin G (IgG). Then, Cin-IgG nanoparticles (NPs) were synthesized and characterized. Finally, the anticancer effects of free Cin and Cin-IgG NPs on MCF-7 breast cancer (BC) cells were evaluated. The results of spectroscopy measurements show that the IgG-Cin complex's quenching mechanism is static and the structure of IgG was partially changed following interaction with Cin. The prepared Cin-IgG NPs display a hydrodynamic size of 190 nm with a PDI of 0.269, a zeta potential of -38.05 mV, an EE% of 72.38 %, a LC% of 5.41 %, and a pH-sensitive drug release behavior. In the cellular assay, it was found that the calculated IC₅₀ concentrations of Cin, IgG NPs, and Cin-IgG NPs are 66.4 ± 5.39, >100, and 29.2 ± ± 4.11 μM, respectively, in MCF-7 BC cells. Finally, Cin-IgG NPs induce a greater effect on the overexpression of the Bax/Bcl-2 ratio and downregulation of PI3K/p-AKT compared to the free drug. In conclusion, this study shows that Cin has the potential to bind IgG as a human plasma protein, and its complexation into a NP form with IgG can boost its anti-BC effects.

01 Jan 2025·BIOCHEMICAL PHARMACOLOGY

Isoginkgetin Inhibits RANKL-induced Osteoclastogenesis and Alleviates Bone Loss

Article

Author: Zou, Jian ; Deng, Wei ; Zhou, Yi ; Wang, Bin ; Zhang, Zhida ; Tang, Kai ; Chen, Junchun ; Wang, Zihe ; Zhao, Wenhua

Osteoporosis is characterized by excessive osteoclast activity leading to bone loss, decreased bone mineral density, and increased susceptibility to fractures. Through in vivo/vitro experiments, along with network pharmacology analysis, we aimed to explore the underlying mechanisms of Isoginkgetin (IGG) in inhibiting osteoclastogenesis, providing valuable insights for further research in the future. Firstly, we ascertained the safe concentration of IGG stimulation on BMMs, followed by a systematic exploration of the concentration gradient at which IGG inhibited osteoclastogenesis using TRAP analysis. An osteoporosis model was established to further validate the in vitro experimental findings by combining Micro-CT and immunohistochemical analysis. The results show that IGG did not exhibit cytotoxicity or proliferative effects on BMMs at concentrations equal to or less than 10 μM. Additionally, IGG inhibited the activity of osteoclastogenesis and bone resorption function at lower concentrations. RT-PCR and Western Blot results demonstrated that IGG could downregulate genes and proteins associated with osteoclastogenesis. The Western Blot results also showed that IGG inhibited the phosphorylation expression of P38, ERK, and P65 in the MAPK and NF-κB pathways. At the same time, it rescued the degradation of IκB-α at 15 and 60 min. IGG can also impact the relative expression levels of oxidative proteins such as SOD-1, HO-1, and catalase, thereby influencing cellular equilibrium and stress levels, ultimately inhibiting the formation of mature OC. In vivo experiments demonstrated that IGG alleviated bone loss caused by osteoclasts and improved relevant parameters of trabecular bone. So, IGG effectively attenuated osteoclastogenesis, and improved bone density, thereby portraying its role in osteoporosis management.

01 Nov 2024·JOURNAL OF CLINICAL IMMUNOLOGY

Insights into Patient Experiences with Facilitated Subcutaneous Immunoglobulin Therapy in Primary Immune Deficiency: A Prospective Observational Cohort

Article

Author: Bilgic Eltan, Sevgi ; Dikici, Ummugulsum ; Ozdemir, Oner ; Can, Salim ; Meric, Zeynep ; Aydogan, Metin ; Yalcin Gungoren, Ezgi ; Orhan, Fazil ; Kiykim, Ayca ; Karabiber, Esra ; Baris, Safa ; Karakoc-Aydiner, Elif ; Ozen, Ahmet ; Yorgun Altunbas, Melek ; Cokugras, Haluk ; Yakici, Nalan ; Eser Simsek, Isil

Abstract:

Background:

Immunoglobulin G replacement therapy (IgRT), intravenous (IV) and subcutaneous (SC) routes, is pivotal in treatment of primary immunodeficiencies (PID). In recent years, facilitated subcutaneous immunoglobulin (fSCIG), a combination of rHuPH20 and 10% IgG has emerged as a delivery method to combine advantages of both IV and SC.

Method:

In an observational prospective cohort, we investigated patient experience with fSCIG in PID patients from 5 PID centers for up to 12 months. We assessed the efficacy and safety of this treatment with patient/caregiver- and physician-reported indicators. Additionally, we analyzed patient treatment satisfaction (TSQM-9) and quality of life (QoL).

Results:

We enrolled 29 patients (22 pediatric and 7 adults; 14 females and 15 males; (median: 15, min–max: 2–40.9 years) who initiated fSCIG as IgRT-naive (n = 1), switched from conventional rapid-push 10% SCIG (n = 6) or IVIG (n = 22). Among the participants, 19 (65%) exhibited antibody deficiencies, 8 (27%) combined immunodeficiencies, and 2 (7%) immune dysregulations. Remarkably, targeted trough immunoglobulin G levels were achieved under all previous IgRTs as well as fSCIG. No severe systemic adverse drug reactions were documented, despite prevalent local (%86.45) and mild systemic (%26.45) adverse reactions were noted with fSCIG. Due to mild systemic symptoms, 2 patients switched from fSCIG to 10% SCIG. The patient satisfaction survey revealed a notable increase at 2-4th (p = 0.102); 5-8th (p = 0.006) and 9-12th (p < 0.001) months compared to the baseline. No significant trends were observed in QoL surveys.

Conclusion:

fSCIG demonstrates admissable tolerability and efficacy in managing PIDs in addition to notable increase of patients’ drug satisfaction with IgRT. The identified benefits support the continuation of this therapy despite the local reactions.

News (Medical) associated with Normal Human Immunoglobulin (CSL Behring)

13 Feb 2024

·www.prnewswire.com

Half year reported NPATA US$2 billion¹,² Up 13% at constant currency³

Strong CSL Behring portfolio growth especially Ig FINANCIAL HIGHLIGHTS 4 Revenue $8.05 billion, up 11% at CC3 NPAT $1.90 billion1, up 17% NPAT $1.94 billion1 at CC3, up 20% NPATA $2.02 billion1,2 , up 11% NPATA $2.06 billion1,2 at CC3, up 13% NPATA1,2 earnings per share $4.182, up 11% NPATA1,2 earnings per share $4.26 at CC3 up 13% Interim dividend 5 of US$1.19 per share Converted to Australian currency, the interim dividend is approximately A$1.81 per share, up 12% Guidance reaffirmed – FY24 NPATA2,4 anticipated to be in the range of approximately $2.9 billion to $3.0 billion2 at CC3 MELBOURNE, Australia, Feb. 13, 2024 /PRNewswire/ -- CSL Limited (ASX:CSL; USOTC:CSLLY) today announces a reported net profit after tax of $1.90 billion1 for the 6 months ended 31 December 2023, up 20% on a constant currency basis3. Underlying profit (NPATA) was $2.02 billion1,2, up 13% on a constant currency basis to $2.06 billion1,2,3. Dr. Paul McKenzie, CSL's Chief Executive Officer and Managing Director said, "Our strong first-half result for the 2024 financial year was driven by CSL Behring's exceptional performance across its portfolio, especially immunoglobulins. The plasma initiatives we have implemented are starting to drive gross margin recovery. "CSL Seqirus achieved solid growth in a challenging season. Its portfolio of differentiated products outperformed the market. "For CSL Vifor we are well prepared for the transitioning iron market." PERFORMANCE CSL Behring Total revenue was $5,238 million, up 14%3 when compared to the prior comparable period. Immunoglobulin (Ig) product sales of $2,757 million, increased 23%3 with strong growth recorded across all geographies driven by global plasma supply and patient demand. PRIVIGEN® / INTRAGRAM® (Immune Globulin Intravenous (Human), 10% Liquid) sales grew 27%3 as the momentum from the prior year continued in improving product availability and patient diagnosis rates. HIZENTRA® (Immune Globulin Subcutaneous (Human), 20% Liquid) sales were up 18%3 driven by patient diagnosis rates. HIZENTRA® continues to be the clear market leader for subcutaneous immunoglobulin. Underlying demand for Ig continues to be strong due to significant patient needs in core indications – namely Primary Immune Deficiency, Secondary Immune Deficiency and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Albumin sales of $613 million, were up 8%3. Sales were strong in emerging markets with solid growth in the US and Europe. Growth in China was modest, tempered by competitive pressure. Haemophilia product sales of $662 million increased 8%3. IDELVION®, CSL Behring's novel long-acting recombinant factor IX product achieved growth of 7%3 and continues to be the market leader in key markets. HEMGENIX®, the first and only gene therapy for haemophilia B was successfully launched in the US in FY23 and patient referrals have been accelerating. The haemophilia A market continued to be competitive resulting in a modest decline in sales for AFSTYLA®, a novel recombinant factor VIII product. Plasma-derived haemophilia products, however, achieved growth of 8% driven by HUMATE® / HAEMATE®, therapies for the treatment of patients with von Willebrand disease. Specialty products sales of $976 million, were up 6%3 led predominately by demand for KCENTRA® and HAEGARDA®. KCENTRA® (4 factor prothrombin complex concentrate) recorded sales growth of 12%3, as it continues to further penetrate the warfarin reversal market in the US. HAEGARDA®, our therapy for patients with Hereditary Angioedema, increased 9%, driven by the continued shift from on-demand to prophylaxis treatment and a strong performance in the UK and Europe. Garadacimab (Anti-FXIIa) for HAE, was filed for regulatory approval in the US and EU. Plasma Collections Plasma collections remain strong. The cost of collections, which includes donor compensation and labour, continued to trend down. A new roll out plan for the RIKA plasmapheresis devices was developed. Deployment across the US fleet is expected over the next 18 months. In addition, results from an individualised nomogram trial conducted by our supplier have been submitted for regulatory approval. CSL Seqirus Total revenue of $1,804 million, was up 2%3 driven by the adjuvanted influenza vaccine FLUAD®, which increased by 14%3. This growth was achieved against a backdrop of reduced rates of immunisation and highlights the strength of CSL Seqirus' differentiated product portfolio. During the period: Self-amplifying mRNA vaccine for COVID was approved by Japan's Ministry of Health, Labour and Welfare aQIVc, a next generation influenza vaccine combining adjuvant technology with cell-based manufacturing, enrolled its last patient in the Phase III clinical study in January 2024. CSL Vifor Total revenue was $1,011 million. The prior comparable period included only 5 months revenue following the acquisition of Vifor Pharma in August 2022. During the period: Preparations were made for the transitioning iron market There was strong performance from the long-acting erythropoiesis-stimulating agent, MIRCERA® TAVNEOS® was successfully launched in multiple European countries While the strategic potential of the business remains strong, we have dampened our near-term growth aspirations for CSL Vifor. Expense Performance Research and development (R&D) expenses were $669 million8 , up 11%3 when compared to the prior comparable period. The increase in expenses reflects higher costs associated with the progression of the R&D portfolio and investment in R&D infrastructure. Selling and marketing expenses (S&M) were $707 million8, up 2%3 in comparison to the prior comparable period. An additional month of CSL Vifor and an increase in labour costs accounts for the increase in S&M expenses while other S&M expenses were held in line with the prior comparable period. General and administrative (G&A) expenses were $323 million8, down 7%3 due to favourable foreign exchange differences and efficiencies generated from the centralisation of the group's Enabling Functions. Depreciation and amortisation (D&A) expense (excluding acquired intellectual property) was $297 million, up 1%3. Net finance costs were $234 million9, up 32%3. The increase in net finance costs was due to the debt associated with the acquisition of Vifor Pharma and higher interest rates. Financial position Cashflow from operations was $1,069 million, up 9%. The increase was driven by higher profitability and overall growth in sales. This was partly offset by higher payments for income tax and interest. Cash outflow from investing was $702 million, down significantly when compared to the prior comparable period as payment for the acquisition of Vifor Pharma was made in the prior period. CSL's balance sheet remains in a strong position with net assets of $19,162 million. Current assets increased by 10% to $10,146 million. The main driver was an increase in receivables due to the increase in sales and the seasonality of CSL Seqirus. Non-current assets increased by 1% to $27,158 million in comparison to the previous year. Current liabilities increased by 2% to $4,718 million. The increase in interest-bearing liabilities and borrowings (bank debt) was offset by the decrease in trade and other payables and current tax liabilities. Non-current liabilities decreased by 3% to $13,424 million. The decrease was due to the reclassification of certain bank borrowings as current, coupled with repayment across the Group's debt portfolio including the private placement senior notes. Outlook (at FY23 exchange rates) Commenting on CSL's outlook, Dr. McKenzie said, "For FY24, I am pleased to reaffirm our previous guidance. CSL's underlying profit, NPATA is expected be in the range of approximately $2.9 billion to $3.0 billion at constant currency3, representing growth over FY23 of approximately 13-17%[6]" "CSL is in a strong position to deliver annualised double-digit earnings growth over the medium term. "The strong growth in our immunoglobulins franchise is expected to continue as patient demand remains strong. "We have a number of initiatives underway in plasma collections that are improving efficiencies and processing times, supporting continued expansion in CSL Behring's gross margin. "Our transformational gene therapy product for haemophilia B patients, HEMGENIX®, is attracting significant interest from patients and health care professionals and patient referrals have accelerated. We expect more patients dosed in the second half of this financial year. "CSL Seqirus has performed well in a challenging season. However, due to the seasonality of this business we anticipate it to post a loss in the second half of the fiscal year. "For CSL Vifor, we are operating within an evolving iron market. While there are challenges for near-term growth, we are well positioned for iron competition in the EU and further geographic expansion. Our focus remains on unlocking value by leveraging capabilities across the CSL group", Dr. McKenzie concluded. In compiling the company's financial forecasts for FY24, a number of key variables that may have a significant impact on guidance have been identified and these have been included in the endnote[7]. FURTHER INFORMATION Additional details about CSL's results are included in the company's 4D statement, investor presentation slides and webcast, all of which can be found on CSL's website A glossary of medical terms can also be found on the website. 1 Attributable to CSL shareholders 2 Statutory net profit after tax (NPAT) before impairment and amortisation of acquired intellectual property, business acquisition and integration costs and the unwind of the inventory fair value uplift. 3 Constant currency (CC) removes the impact of exchange rate movements, facilitating the comparability of operational performance. For further detail refer to CSL's Financial Statements for the Half Year ended December 2023 (Directors Report). 4 All figures are expressed in US dollars unless otherwise stated. 5 For shareholders with an Australian registered address, the interim dividend of US$1.19 per share (approximately A$1.81) is expected to be paid on 3 April 2024. For shareholders with a New Zealand registered address the interim dividend of US$1.19 per share (approximately NZ$1.94) is expected to be paid on 3 April 2024. The exchange rates will be fixed at the record date of 12 March 2024. All other shareholders will be paid in US$. CSL also offers shareholders the opportunity to receive dividend payments in US$ by direct credit to a US bank account. 6 % growth rates excludes the one-off gain from the sale of property in FY23 (NPATA $44m). 7 Key variables that could cause actual results to differ materially include: the success and timing of research and development activities; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; competitive developments affecting our products; the ability to successfully market new and existing products; difficulties or delays in manufacturing; ability to collect plasma; trade buying patterns and fluctuations in interest and currency exchange rates; legislation or regulations that affect product production, distribution, pricing, reimbursement, access or tax; acquisitions and divestitures; research collaborations; litigation or government investigations; and CSL's ability to protect its patents and other intellectual property. 8 Underlying results are adjusted to exclude amortisation of acquired intellectual property ($132 million), business acquisition and integrations costs and the unwind of the inventory fair value uplift. 9 At reported currency For further information, please contact: Investors: Bernard Ronchi Director, Investor Relations CSL Limited P: +61 3 9389 3470 E: [email protected] Stephen McKeon Director, Investor Relations CSL Limited P: +61 402 231 696 E: [email protected] Media: Jimmy Baker Communications CSL Limited P: +61 450 909 211 E: [email protected] SOURCE CSL Limited

Phase 3Drug ApprovalVaccineFinancial StatementClinical Result

16 Jan 2024

·www.fiercepharma.com

CSL, readying for argenx rivalry, asks autoimmune patients what they want from therapies

Most patients are interested in exploring more convenient treatment options. CSL Behring has identified what it will take to win in a major autoimmune market. Ahead of a potential approval of argenx’s rival drug, the company surveyed people with chronic inflammatory demyelinating polyneuropathy (CIDP)—and emerged with evidence of an appetite for more convenient treatments. The existing treatment options in CIDP include a pair of CSL products, the intravenous Privigen and the subcutaneous, self-administered Hizentra. Use of Hizentra is limited to maintenance therapy. Later this year, argenx expects to win FDA approval for Vyvgart Hytrulo, a subcutaneous product with a different mechanism of action. The drug will provide competition to products that drove growth at CSL last year. CSL commissioned Harris Poll to help understand what factors will determine the winners of the next era of the CIDP market. The survey included 100 people living with the condition, including 98 who were on treatment, and 100 specialist physicians who regularly see at least one CIDP patient. Most (82%) patients are interested in exploring more convenient treatment options. Administering the drug at home, something made possible by Hizentra, is extremely or very important to 72% of the respondents. Home administration trailed the three non-negotiables—efficacy, minimal side effects and condition maintenance—on the list of priorities when patients consider new therapies. While patients are open to new therapies, some encouragement and education may be needed to get people to seek out alternatives to their current treatments. Less than half of the respondents discuss new treatment options and switching drugs with their physicians, and similarly few people have a good grasp of how different therapies work and are administered. CSL, which is set to start selling a higher dose of Hizentra, is pitching its subcutaneous product as the answer to demands for more convenient treatment options. Argenx’s FcRn drug Vyvgart Hytrulo, which is given subcutaneously but must be administered by a healthcare professional in its existing indication, is on track to win approval in CIDP and launch in the U.S. around the middle of the year. At an investor event in October, Andy Schmeltz, executive vice president of the CSL Behring business unit, said he expects Privigen and Hizentra “to maintain compelling leadership positions in CIDP and in all core indications given their well-established and well characterized benefit risk profile, their proven long-term protection, physician clinical experience and strong placement in treatment guidelines.” Schmeltz added that “in CIDP, in particular, we look forward to competing with FcRns, both offensively and defensively, reinforcing the compelling benefit risk profile of Ig therapy.” CSL has a lot riding on the products. Privigen and Hizentra brought in (PDF) $2.8 billion and $1.6 billion, respectively, in the year ended 30 June. The figures represented 29% growth for Privigen and 12% growth for Hizentra.

Drug ApprovalFinancial Statement

16 Jan 2024

·www.prnewswire.com

Harris Poll Survey Finds People Receiving Treatment for CIDP Are Interested in Exploring More Convenient Treatment Options

Findings show that convenience of treatment and flexibility of administration, such as at-home treatment options, are of high importance to patients KING OF PRUSSIA, Pa., Jan. 16, 2024 /PRNewswire/ -- CSL Behring, a business unit of global biotechnology leader CSL, today announced survey results showing that the majority of surveyed people living with chronic inflammatory demyelinating polyneuropathy (CIDP) agree they are interested in exploring more convenient treatment options (n=98, 82%) and that administering treatment at home is extremely/very important to them (n=100, 72%). However, less than half of people surveyed said they discuss potential new treatment options or switching treatments with a physician (n=100, 47% and 43% respectively). The CSL Behring-sponsored Harris Poll survey included 100 people living with CIDP, 98 of whom were currently on treatment for their CIDP, and 100 neurologists/neuromuscular specialists who regularly see at least one patient with CIDP. CIDP is a rare autoimmune disorder that affects the peripheral nerves (those outside the brain and spinal cord) and damages the protective covering of the nerves known as the myelin sheath. CIDP symptoms can worsen over time, leading to significant activity limitations. In the survey (n=100), 57% of patients said they wish their physicians better understood what they think is important in a CIDP treatment with the majority listing efficacy (95%), minimal side effects (97%), condition maintenance (96%), at-home administration (72%) and flexible dosing options (70%), among their top priorities when thinking about a treatment option. Additionally, less than half of patients surveyed said they are very/somewhat knowledgeable about how different CIDP treatment options work (40%) or about how different CIDP treatment options are administered (45%). "We know that people living with rare diseases benefit from shared decision-making with their physician about their treatment options, including how and where they receive treatment," said Dr. Jeffrey Allen, MD, Associate professor of neurology at the University of Minnesota Medical School. "Having regular open discussions about the different options available, including self-administered treatment at home for CIDP maintenance for example, is particularly important for people who may find it difficult or burdensome to travel to an infusion center." CSL Behring's Hizentra® (Immune Globulin Subcutaneous [Human] 20 percent Liquid) is the first and only self-administered, subcutaneous immunoglobulin (SCIg) for the treatment of CIDP as maintenance therapy to prevent relapse of neuromuscular disability and impairment. As Hizentra is infused under the skin and not into a vein, people with CIDP can use Hizentra at home and don't have to worry about finding a vein, which is especially important for those who may have venous access issues. For additional convenience, Hizentra is available in vials or a wide range of prefilled syringe sizes, including 1g, 2g, 5g and a 10g size that will be available in early 2024. "As part of Our Promise, we are committed to listening to and understanding the concerns of people living with rare diseases and developing treatment options that address unmet needs," said Bob Lojewski, Senior Vice President and General Manager, North America, CSL Behring. "We are proud to be at the forefront of delivering both effective and convenient treatment options like Hizentra, which may allow those living with CIDP more flexibility by allowing them to self-administer their treatment at home. Furthermore, to help improve the treatment experience, we are proud to offer Hizentra in a range of prefilled syringe sizes, including a soon to be available 10g prefilled syringe." For more information, visit please visit Hizentra.com. About the Survey The survey was conducted on behalf of CSL Behring with 100 people living with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and 100 neurologists/neuromuscular specialists. The survey took place between February 27, 2023 and March 15, 2023. Patients were identified and recruited directly by treating physicians. Both patients and physicians were fully screened for eligibility. The survey qualification criteria for patients included being age 18+, residency in the U.S. and CIDP diagnosis. The survey qualification criteria for physicians included that they practice in the U.S., are duly licensed, are neurologists/neuromuscular specialists and regularly see at least one patient with CIDP. About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) CIDP is a rare autoimmune disorder that affects the peripheral nerves (those outside the brain and spinal cord) and damages the protective covering of the nerves known as the myelin sheath. This may result in numbness or tingling, muscle weakness, fatigue and other symptoms. CIDP symptoms can worsen over time, leading to significant activity limitations and a decreased quality of life. CIDP can occur at any age and is more common in men than in women. Approximately 30 percent of CIDP patients progress to wheelchair dependence if not treated. The GBS|CIDP Foundation estimates that the incidence of CIDP in the U.S. is as high as two in 100,000 people each year, with the accumulation of cases over time resulting in prevalence as high as nine in 100,000 in some areas. About Hizentra® Registered in more than 60 countries, Hizentra is the most prescribed subcutaneous immunoglobulin for primary immunodeficiency (PI) in the U.S. It has a proven track record of safety, efficacy, and tolerability. Hizentra was first approved by the U.S. FDA in March 2010 for the treatment of patients with PI and was approved in March 2018 for the treatment of adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) to prevent relapse of neuromuscular disability and impairment. For more information about Hizentra, including the U.S. prescribing information, visit . Important Safety Information (ISI) WARNING: Thrombosis (blood clots) can occur with immune globulin products, including Hizentra. Risk factors can include: advanced age, prolonged immobilization, a history of blood clotting or hyperviscosity (blood thickness), use of estrogens, installed vascular catheters, and cardiovascular risk factors. If you are at high risk of blood clots, your doctor will prescribe Hizentra at the minimum dose and infusion rate practicable and will monitor for signs of clotting events and hyperviscosity. Always drink sufficient fluids before infusing Hizentra. See your doctor for a full explanation, and the full prescribing information for complete boxed warning. Hizentra®, Immune Globulin Subcutaneous (Human), 20% Liquid, is a prescription medicine used to treat: Primary immune deficiency (PI) in patients 2 years and older Chronic inflammatory demyelinating polyneuropathy (CIDP) in adults Treatment with Hizentra might not be possible if your doctor determines you have hyperprolinemia (too much proline in the blood), or are IgA-deficient with antibodies to IgA and a history of hypersensitivity. Tell your doctor if you have previously had a severe allergic reaction (including anaphylaxis) to the administration of human immune globulin. Tell your doctor right away or go to the emergency room if you have hives, trouble breathing, wheezing, dizziness, or fainting. These could be signs of a bad allergic reaction. Inform your doctor of any medications you are taking, as well as any medical conditions you may have had, especially if you have a history of diseases related to the heart or blood vessels, or have been immobile for some time. Inform your physician if you are pregnant or nursing, or plan to become pregnant. Infuse Hizentra under your skin only; do not inject into a blood vessel. Self-administer Hizentra only after having been taught to do so by your doctor or other healthcare professional, and having received dosing instructions for treating your condition. Immediately report to your physician any of the following symptoms, which could be signs of serious adverse reactions to Hizentra: Reduced urination, sudden weight gain, or swelling in your legs (possible signs of a kidney problem). Pain and/or swelling or discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, or numbness/weakness on one side of the body (possible signs of a blood clot). Bad headache with nausea; vomiting; stiff neck; fever; and sensitivity to light (possible signs of meningitis). Brown or red urine; rapid heart rate; yellowing of the skin or eyes; chest pains or breathing trouble; fever over 100°F (possible symptoms of other conditions that require prompt treatment). Hizentra is made from human blood. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated. The most common side effects in the clinical trials for Hizentra include redness, swelling, itching, and/or bruising at the infusion site; headache; chest, joint or back pain; diarrhea; tiredness; cough; rash; itching; fever, nausea, and vomiting. These are not the only side effects possible. Tell your doctor about any side effect that bothers you or does not go away. Before receiving any vaccine, tell immunizing physician if you have had recent therapy with Hizentra, as effectiveness of the vaccine could be compromised. Please see full prescribing information for Hizentra, including boxed warning and the patient product information. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088. You can also report side effects to CSL Behring's Pharmacovigilance Department at 1-866-915-6958. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSLBehring. Media Contact Etanjalie Ayala Mobile: +1 610 297 1069 Email: [email protected] SOURCE CSL Behring

Drug ApprovalClinical ResultImmunotherapy

100 Deals associated with Normal Human Immunoglobulin (CSL Behring)

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Secondary immunodeficiencies	EU	CSL Behring GmbH	14 Apr 2011
Secondary immunodeficiencies	IS	CSL Behring GmbH	14 Apr 2011
Secondary immunodeficiencies	LI	CSL Behring GmbH	14 Apr 2011
Secondary immunodeficiencies	NO	CSL Behring GmbH	14 Apr 2011
Acquired Immunodeficiency Syndrome	EU	CSL Behring GmbH	24 Apr 2008
Acquired Immunodeficiency Syndrome	IS	CSL Behring GmbH	24 Apr 2008
Acquired Immunodeficiency Syndrome	LI	CSL Behring GmbH	24 Apr 2008
Acquired Immunodeficiency Syndrome	NO	CSL Behring GmbH	24 Apr 2008
Agammaglobulinemia	EU	CSL Behring GmbH	24 Apr 2008
Agammaglobulinemia	IS	CSL Behring GmbH	24 Apr 2008
Agammaglobulinemia	LI	CSL Behring GmbH	24 Apr 2008
Agammaglobulinemia	NO	CSL Behring GmbH	24 Apr 2008
Bacterial Infections	EU	CSL Behring GmbH	24 Apr 2008
Bacterial Infections	IS	CSL Behring GmbH	24 Apr 2008
Bacterial Infections	LI	CSL Behring GmbH	24 Apr 2008
Bacterial Infections	NO	CSL Behring GmbH	24 Apr 2008
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	US	CSL Behring AG	26 Jul 2007
Primary Immunodeficiency Diseases	US	CSL Behring AG	27 Jul 2000
Purpura, Thrombocytopenic, Idiopathic	US	CSL Behring AG	27 Jul 2000

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Post Acute COVID 19 Syndrome	Phase 3	US	CSL Behring LLC	28 Aug 2024
Post Acute COVID 19 Syndrome	Phase 3	CA	CSL Behring LLC	28 Aug 2024
Postural Orthostatic Tachycardia Syndrome	Phase 3	US	CSL Behring LLC	28 Aug 2024
Postural Orthostatic Tachycardia Syndrome	Phase 3	CA	CSL Behring LLC	28 Aug 2024
Dermatomyositis	Phase 3	US	CSL Behring LLC	21 Oct 2019
Dermatomyositis	Phase 3	JP	CSL Behring LLC	21 Oct 2019
Dermatomyositis	Phase 3	AR	CSL Behring LLC	21 Oct 2019
Dermatomyositis	Phase 3	BE	CSL Behring LLC	21 Oct 2019
Dermatomyositis	Phase 3	FR	CSL Behring LLC	21 Oct 2019
Dermatomyositis	Phase 3	DE	CSL Behring LLC	21 Oct 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02465359 (SCIG, CTgov)	Not Applicable	Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	15	Immune Globulin Subcutaneous (Human)	sltjprijtf(leegcunzlt) = jslpyyvhls pdgsnpdayv (xxykcioqwn, fmbaalitaj - muldqieycu) View more	-	08 Oct 2024
NCT03919773 (iSTAND, CTgov)	Phase 1/2	Postural Orthostatic Tachycardia Syndrome	30	IVIg (Treatment IVIG Arm)	ehnspaxhut(kamgmbizil) = occjnamdop wxmdhparow (iwvwvdxuqx, tgdfkdfwjg - sgtihuwvxi) View more	-	19 Sep 2024
NCT03919773 (iSTAND, CTgov)	Phase 1/2	Postural Orthostatic Tachycardia Syndrome	30	albumin (Treatment Albumin Arm)	ehnspaxhut(kamgmbizil) = ldryvesvlx wxmdhparow (iwvwvdxuqx, tnavhnxexc - lcjwymztci) View more	-	19 Sep 2024
AAAAI2024	Not Applicable	Primary Immunodeficiency Diseases	-	Immune Globulin Subcutaneous 16.5%	dkhrzsoibj(rnvtlkbqoi) = hpubaureip ckqfheuthc (ujkftsfdga ) View more	Positive	23 Feb 2024
AAAAI2023	Not Applicable	Primary Immunodeficiency Diseases	57	IGSC 16.5%	nhntpynmev(gyenqcldfy) = 44 bacterial RTIs were reported in 29 patients (rate of 0.77 infections/patient/year), with 1 serious yikpfzhwcm (zdhnnaovah )	-	01 Feb 2023
EHA2021	Not Applicable	Chronic Lymphocytic Leukemia	10	Subcutaneous Immunoglobulins	fitlfuadyq(bkstdvlkvs) = mceafmvigp vordkunszn (xardxfofzr )	-	09 Jun 2021
NCT04044690 (Pubmed \| Rheumatology (Oxford)) Manual	Phase 3	Myositis First line	20	Privigen	vflsgeoufm(seoexopflz) = wsxcsykqkk cwhfoupldi (nuvpowrefl ) View more	Positive	06 Apr 2021
NCT03593902 (CAST, CTgov)	Phase 2/3	Scleroderma, Systemic	9	Autologous Stem Cells+Mesna+Methylprednisolone+Fludarabine+CYCLOPHOSPHAMIDE+rATG+G-CSF+IVIg+Rituximab	ysyphljkxt(ddzjuhmsyr) = ntzvwvsqyn bdzhrinnfq (zvjnrbkfvy, eggxvmvbbz - ektdxsaggi) View more	-	12 Aug 2020
NCT03033745 (HILO Study, AAAAI2020)	Phase 4	Primary Immunodeficiency Diseases	16	Manual IgPro20 push infusions at high flow rate	aubnbulbax(miwdxcoqgk) = zsvbkpvvxv lphlauzhty (mzqjhrjaby )	-	01 Feb 2020
AAAAI2020	Not Applicable	Primary Immunodeficiency Diseases	33	IGSC 16.5%	utehsupxny(fadllwhrha) = A total of 22/33 (67%) patients reported local-site reactions (rate 0.60/infusion), with injection pain and swelling most common. Systemic reactions were reported in 20/33 (61%) of patients (0.47/infusion), with headache and fatigue most common. Incidence of reactions was highest with the first infusion. Therapy was discontinued in one per patient request kiatwehrku (bjqcjlnruu ) View more	-	01 Feb 2020

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