Delving into the Latest Updates on Immunoglobulin(Baxalta Innovations GmbH) with Synapse

Overview

Basic Info

Drug Type

Immunoglobulin

Synonyms

human normal immunoglobulin(Baxter ), Subcuvia

Target-

Mechanism-

Therapeutic Areas-

Active Indication-

Inactive Indication-

Originator Organization

Baxalta Innovations GmbH

Active Organization

Baxalta Innovations GmbH

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

DE (05 Aug 2004)

Regulation-

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Kawasaki disease is a pediatric acute systemic vasculitis that specifically involves the coronary arteries. Timely initiation of immunoglobulin plus aspirin is necessary for diminishing the incidence of coronary artery abnormalities (CAAs). The optimal dose of aspirin, however, remains controversial. The trial aims to evaluate if low-dose aspirin is noninferior to moderate-dose in reducing the risk of CAAs during the initial treatment of Kawasaki disease.

METHODS:

This is a multi-center, prospective, randomized, open-label, blinded endpoint, noninferiority trial to be conducted in China. The planned study duration is from 2023 to 2026. Data will be analyzed according to intention-to-treat principles. Participants are children and adolescents under the age of 18 with Kawasaki disease, recruited from the inpatient units. A sample size of 1,346 participants will provide 80% power with a one-sided significance level of 0.025. Qualifying children will be randomized (1:1) to receive either intravenous immunoglobulin (2 g/kg) plus oral moderate-dose aspirin (30-50 mg·kg^-1·d^-1) until the patient is afebrile for at least 48 hours, or immunoglobulin plus low-dose aspirin (3-5 mg·kg^-1·d^-1) as initial treatment. The primary outcome will be the occurrence of CAAs at 8 weeks after immunoglobulin infusion. Independent blinded pediatric cardiologists will assess the primary endpoint using echocardiography.

CONCLUSIONS:

There is a shortage of consensus on the dose of aspirin therapy for Kawasaki disease due to the lack of evidence. The results of our randomized trial will provide more concrete evidence for the efficacy and adverse events of low- or moderate-dose aspirin in the acute phase of Kawasaki disease.

TRIAL REGISTRATION:

www.chictr.org.cn: ChiCTR2300072686.

09 Apr 2024·Blood advances

Immunoglobulin replacement vs prophylactic antibiotics for hypogammaglobulinemia secondary to hematological malignancy

Article

Author: Trotman, Judith ; Pepperell, Dominic ; Dendle, Claire ; Pullon, Humphrey ; Wood, Erica M ; Waters, Neil ; Thao, Le Thi Phuong ; Keegan, Anastazia ; Gilbertson, Michael ; Wellard, Cameron ; van Tonder, Tina ; Weinkove, Robert ; Weston, Helen ; Johnston, Anna ; Crispin, Philip ; Degelia, Amber ; Morrissey, C Orla ; Reynolds, John ; McQuilten, Zoe K

Abstract:

Immunoglobulin replacement and prophylactic antibiotics are commonly used to prevent infections in patients with secondary hypogammaglobulinemia due to hematological malignancies but have never been directly compared. In this randomized controlled feasibility trial conducted in 7 hospitals in Australia and New Zealand, we enrolled patients with secondary hypogammaglobulinemia with either a history of recurrent/severe infection or an immunoglobulin G level <4 g/L. Participants were randomized in a 1:2 ratio to immunoglobulin (0.4 g/kg per 4 weeks IV) or daily antibiotics (trimethoprim-sulfamethoxazole 160 mg/800 mg or, if contraindicated, 100 mg doxycycline) for 12 months. Participants allocated to antibiotics were allowed to crossover after grade ≥3 infections. The primary outcome was proportion of patients alive on the assigned treatment 12 months after randomization. Between August 2017 and April 2019, 63 patients were randomized: 42 to antibiotics and 21 to immunoglobulin. Proportion of participants alive on allocated treatment at 12 months was 76% in the immunoglobulin and 71% in the antibiotic arm (Fisher exact test P=.77; odds ratio, 0.78; 95% CI, 0.22-2.52). The lower quartile for time to first major infection (median, not reached) was 11.1 months for the immunoglobulin and 9.7 months for the antibiotic arm (log-rank test, P=.65). Three participants in the immunoglobulin and 2 in the antibiotic arm had grade ≥3 treatment-related adverse events. A similar proportion of participants remained on antibiotic prophylaxis at 12 months to those on immunoglobulin, with similar rates of major infections. Our findings support the feasibility of progressing to a phase 3 trial. Trial registration #ACTRN12616001723471.

05 Mar 2024·Journal of chest surgery

Successful Heart Transplantation Despite Rhesus Blood Type Mismatch: A Case Report

Author: Shin, Yu-Rim ; Kim, Ji Hong

Matching for the rhesus (Rh) blood group is currently not taken into account in the organ allocation system. However, in Rh-mismatched transplantation, the primary concern is the potential for RhD-negative recipients to develop sensitization and produce anti-D anti-bodies if they receive a transfusion of RhD-positive blood. It is estimated that over 80% of RhD-negative recipients may experience Rh allosensitization when exposed to RhD-positive blood, although this occurrence is less common in recipients of solid organs. In theory, RhD-negative recipients who receive organs from RhD-positive donors are at risk of alloimmunization and the production of anti-D antibodies, which could complicate future blood product transfusions. However, our understanding of the impact of donor-recipient Rh mismatch on transplant outcomes, particularly in heart transplantation, is limited. We report a case of successful Rh-mismatched heart transplantation, which was effectively managed through the use of preoperative RhD immunoglobulin and plasmapheresis.

1

News (Medical) associated with Immunoglobulin(Baxalta Innovations GmbH)

07 Nov 2023

·www.biospace.com

KORU Medical Systems, Inc. Receives FDA 510(k) Clearance for FREEDOM60® Infusion System With Hizentra® 50 ML Prefilled Syringes

MAHWAH, N.J.--(BUSINESS WIRE)-- KORU Medical Systems, Inc. (NASDAQ: KRMD) ("KORU Medical" or the "Company"), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and easy-to-use specialty subcutaneous infusion solutions that improve quality of life for patients, today announced that it received U.S. Food and Drug Administration (FDA) clearance for use of the FREEDOM60® Infusion System with Hizentra® 50 mL prefilled syringes (PFS). “Being the first and only FDA-cleared infusion system for use with prefilled syringes demonstrates KORU Medical’s continued commitment to enhance the patient experience for all patients self-administering subcutaneous immunoglobulin (SCIg) therapy in the home,” said Linda Tharby, KORU Medical’s President and CEO. “Prefilled syringes are proven to provide a significant improvement in ease of use for all patients, and in administering higher doses of immunoglobulin, including for PIDD and CIDP patients. We are now able to deliver PFS benefits to Hizentra® patients through our FREEDOM™ Infusion System portfolio - the FREEDOM60® Infusion System with 50 mL PFS and the FreedomEdge® with 20 mL PFS. We believe the unlocking of these PFS benefits through use with the FREEDOM™ Infusion System could lead to even greater opportunity to expand SCIg use in the home.” The FREEDOM™ Infusion System is the first and only infusion system cleared for use with prefilled syringes and, given the majority of patients are prescribed doses of 50 mL or greater, this clearance for FREEDOM60® significantly expands the benefits of PFS use, especially for those diagnosed with conditions requiring significantly higher doses of immunoglobulin. When using prefilled syringes with the FREEDOM™ Infusion System, KORU Medical has demonstrated that patients can experience up to an 80% reduction in drug preparation tasks when compared to using vials. The FDA approved the Hizentra® 50 mL prefilled syringe in April 2023, and CSL Behring has announced an early 2024 availability. Hizentra® is the most prescribed subcutaneous immunoglobulin and the first to be available in prefilled syringes. About KORU Medical Systems KORU Medical Systems develops, manufactures, and commercializes innovative and easy-to-use subcutaneous drug delivery systems that improve quality of life for patients around the world. The FREEDOM™ Infusion System currently includes the FREEDOM60® and FreedomEdge® Syringe Infusion Drivers, Precision Flow Rate Tubing™ and HIgH-Flo Subcutaneous Safety Needle Sets™. The FREEDOM™ Infusion System is used for infusions administered in the home and alternate care settings. For more information, please visit . Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. All statements that are not historical fact are forward-looking statements and can be identified by words such as "believe," “could” and "opportunity". Actual results may differ materially from these statements due to potential risks and uncertainties such as, among others, timing of Hizentra® 50 mL prefilled syringe availability, patient acceptance of PFS with the FREEDOM™ Infusion System, and those risks and uncertainties included under the captions "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2022 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, which are on the SEC and available on our website at and on the SEC website at . All information provided in this release and in the attachments is as of November 7, 2023. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. We undertake no duty to update this information unless required by law. Hizentra® is a registered trademark of CSL Behring AG. Hizentra® is manufactured by CSL Behring AG and distributed by CSL Behring LLC.

Drug Approval

100 Deals associated with Immunoglobulin(Baxalta Innovations GmbH)

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R&D Status

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EHA2022	Not Applicable	Multiple Myeloma	2,445	IMMUNOGLOBULIN (Patients who received Ig)	lsnyrikrfl(heptqtdvww) = suaomclhry iekhwmzuks (ioxhxmgdsw )	-	12 May 2022
				IMMUNOGLOBULIN (Patients who did not receive Ig)	lsnyrikrfl(heptqtdvww) = chghncfiya iekhwmzuks (ioxhxmgdsw )
Pubmed	Not Applicable	Pulmonary Disease, Chronic Obstructive serum IgG level	-	IVIG	hwoafhxbis(joadiyvevm) = wwgljtmngx mewgcumodn (gvidtmmkxx )	-	01 Dec 2021
				Normal saline	hwoafhxbis(joadiyvevm) = sqlrfryqes mewgcumodn (gvidtmmkxx )
ASN2021	Not Applicable	Kidney Failure, Chronic	42	Moderna vaccine	mjbspzuiwx(eoxksiisih) = nobvwhzxhp nxwdlylufn (ucckllsdzd ) View more	Positive	27 Oct 2021
				Pfizer vaccine	mjbspzuiwx(eoxksiisih) = ecuajmlnwr nxwdlylufn (ucckllsdzd ) View more
AAN2019	Not Applicable	Hashimoto's Encephalitis	-	Intravenous Immunoglobulin (IVIG)	crxfmmsuuj(iwixmdipml) = gadevgkynb otgkvtcagl (mygiqmgmeh )	-	09 Apr 2019
				Plasma Exchange (PLEX)	crxfmmsuuj(iwixmdipml) = xkspfkuysh otgkvtcagl (mygiqmgmeh )
NCT01824251 (Pubmed \| J Neurol Neurosurg Psychiatry) Manual	Phase 3	Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	49	immunoglobulin	xtaunhwhtf(iwfguldopz) = jtyoyjqvpt dasnzktnjv (wsgodoqicu, 3 - 25) View more	Positive	01 Oct 2017
NCT01412385 (Pubmed \| Clin Exp Immunol) Manual	Phase 2/3	Primary Immunodeficiency Diseases	49	Subcutaneous immunoglobulin	vlhtdubyma(lkjdkdwtno) = 0.022/patient-year oxvbaarjhj (wknlqszfrd ) View more	Positive	01 Jan 2017
P5.044 (AAN2016)	Not Applicable	Polyradiculoneuropathy, Chronic Inflammatory Demyelinating \| Multiple Myeloma	-	IVIG	axnbacwnwl(mhfrmlymur) = rbvxjujqaa qflktmloqc (kbzwgenkbt ) View more	-	05 Apr 2016
				Immunoglobulin	axnbacwnwl(mhfrmlymur) = klgidbnsha qflktmloqc (kbzwgenkbt ) View more
NNINDS 1R01NS093653 (ANA2015)	Not Applicable	Small Fiber Neuropathy autoimmunity	30	IVIG 2 grams/kg/4 weeks	pwwrnwvksg(xemeaahvfi) = fgzrytsfpm thkhxahqtc (eumqhzhjnd, 2.5)	Positive	25 Sep 2015
SP153 (ERA2015)	Not Applicable	Glomerulonephritis, Membranous IgG \| IgM \| IgA	61	IMMUNOGLOBULIN	xfjszcdmkr(kcvayhpwgt) = rzgnxpgvyf qyapwlbise (sctcqohimz )	Negative	21 May 2015
				IMMUNOGLOBULIN	xfjszcdmkr(gzbmpcvrfj) = sulujuymyw fzrasqgnws (zhluthfqbw ) View more