CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), CD20-directed cytolytic effects

Therapeutic Areas

Immune System DiseasesNervous System DiseasesOther Diseases

Active Indication

Multiple SclerosisMultiple sclerosis relapseMultiple Sclerosis, Primary Progressive+ [5]

Inactive Indication

Hashimoto's EncephalitisLupus NephritisRheumatoid Arthritis+ [1]

Originator Organization

Genentech, Inc.

Biogen Idec Ltd.

Active Organization

Hoffmann-La Roche, Inc.

Roche Holding AG

Genentech, Inc.

+ [4]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (28 Mar 2017),

Multiple sclerosis relapseMultiple Sclerosis, Primary Progressive

RegulationFast Track (US)

Gene Sequence

Sequence Code 31212L

Source: *****

Sequence Code 42721H

Source: *****

132

Clinical Trials associated with Ocrelizumab

ChiCTR2400083807 / SuspendedPhase 2IIT

A Study on the Efficacy and Safety of Ocrelizumab in the Treatment of AchR Antibody Positive Generalized Myasthenia Gravis Patients

Start Date04 May 2024

Sponsor / Collaborator

Peking University People's Hospital

NCT06121349 / RecruitingNot Applicable

The Wearing-off Effect of Anti-CD20 Therapies in Patients With Multiple Sclerosis

The nature, intensity, and prevalence of this wearing-off effect remain poorly understood. To our knowledge, there is no consensus in the literature on what symptoms constitute a wearing-off effect, nor is there a single validated scale that measures wearing-off effect. The current study will explore the wearing-off effect associated with OCR and OMB, using a variety of validated scales assessing MS symptoms (i.e., fatigue, mobility, pain, depression, cognition), as well as some global questions on wearing-off. In addition, impact of worsening of MS symptoms on patients' health-related quality of life (HRQoL) and their work productivity will be assessed using relevant MS-specific validated scales

Start Date04 Dec 2023

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT05999604 / RecruitingPhase 3

Impact of Annual Versus Biannual Infusions of Ocrelizumab in Patients With Active MS,After 2 Years of Initial Treatment, on Freedom From Radiological Disease Activity at Two Years: a Multicenter Randomized Controlled Non-inferiority Trial

Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system and the leading cause of severe non-traumatic disability in young people, affecting 110,000 people in France. Ocrelizumab, a humanized anti-CD20 monoclonal antibody, has shown remarkable efficacy in Phase III trials on the inflammatory component of the disease, reducing the annualized relapse rate by 46% and the rate of new T2 lesions by 80% compared with interferon-β 1a.
The use of anti-CD20 agents, including ocrelizumab, is associated with an infectious risk that increases with duration of exposure, part of which is due to the development of hypo-gammaglobulinemia in relation to cumulative dose.
Several reports suggest a persistent effect of anti-CD20 drugs in MS, with no resumption of inflammatory activity after discontinuation:
During the development of ocrelizumab, at the end of phase 2, after having received 3 or 4 semi-annual cycles of ocrelizumab, a safety period with a therapeutic window of 18 months was planned, before re-administration in the extension study. During this therapeutic window, the annualized relapse rate remained stable, and patients showed no radiological disease activity.
Scandinavian observational studies of "off-label" use of anti-CD20 in MS provide real-life evidence of the absence of recovery of clinical and radiological activity after prolonged interruption of treatment.
After 2 years of treatment, and with disease activity under control, spacing administration intervals could reduce the risk of infection without reducing treatment efficacy. This would facilitate the decision to maintain highly active immunotherapy over the long term. In addition, this therapeutic de-escalation, by reducing the frequency of infusions and associated day hospitalizations, would help to reduce treatment management costs.
Our aim is to evaluate the non-inferiority of 12-monthly spacing of ocrelizumab infusions versus the conventional 6-monthly regimen, in a population of active MS patients over 18 years of age who have already received 4 or more semi-annual cycles of treatment for 2 years.

Start Date09 Nov 2023

Sponsor / Collaborator

Fondation Ophtalmologique Adolphe de Rothschild

100 Clinical Results associated with Ocrelizumab

100 Translational Medicine associated with Ocrelizumab

100 Patents (Medical) associated with Ocrelizumab

1,211

Literatures (Medical) associated with Ocrelizumab

01 Apr 2024·Seminars in arthritis and rheumatism

Predictors and prognostic factors influencing outcomes of anti-CD20 monoclonal antibodies in systemic lupus erythematosus: A systematic review update

Review

Author: Dyball, Sarah ; Mendoza-Pinto, Claudia ; Bruce, Ian N ; Parker, Ben ; Rodziewicz, Mia ; Munguía-Realpozo, Pamela

BACKGROUND:

Anti-C20 monoclonal antibodies (MAb), such as rituximab, are commonly used for the treatment of patients with severe or refractory systemic lupus erythematosus (SLE) but clinical outcomes are highly variable. We aimed to provide an update of a systematic review of predictive and prognostic factors of anti-CD20 MAb treatment in SLE.

METHODS:

A systematic literature search was undertaken to identify predictive and prognostic factors of clinical response following treatment with anti-CD20 therapies in SLE patients. Studies examining rituximab published prior to 2015 were excluded. Risk of bias was assessed for randomized controlled trials (RCTs) using the Cochrane Collaboration (RoB2) tool for RCTs and the Quality In Prognosis Studies Tool (QUIPS) for cohort studies. A narrative synthesis of the evidence was undertaken and quality of evidence (QoE) was assessed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.

RESULTS:

From 850 studies identified, 17 studies met the inclusion criteria. A further 8 studies were identified and included through search updates. There were two post-hoc analyses of RCTs of rituximab, one RCT of ocrelizumab and one of obinutuzumab; and 16 cohort studies examining rituximab treatment. The overall QoE was low or very low. There was wide heterogeneity in definitions of clinical disease activity and outcome measures, non-standardized laboratory cut-offs, failure to account for confounders and multiple subgroup analyses of differing outcomes. B cell depletion as well as novel biomarkers, such as S100 proteins, FCGR genotype, anti-vimentin and anti-drug antibodies showed some evidence of prognostic value but QoE was limited due to moderate to high risk of bias, early phase of investigation and imprecision of results.

CONCLUSION:

There has been no validation of previously identified prognostic factors to guide outcome in anti-CD20 treated lupus patients. Hypothesis-driven studies of several novel markers however, demonstrate prognostic value and require replication and validation to support their use in routine clinical practice.

PROSPERO REGISTRATION NUMBER:

CRD42020220339.

01 Feb 2024·Multiple sclerosis and related disorders

Quantifying the administration and monitoring time burden of several disease-modifying therapies for relapsing multiple sclerosis in the United Kingdom: A time and motion study

Article

Author: Amin, Amerah ; De Cock, Erwin ; Ashton, Luke ; Lowndes, Claire ; Pendlebury, Jessica ; Kalra, Seema ; Leclerc, Stephanie ; Evans, Hannah ; Brownlee, Wallace ; Barker, Noreen ; Carod-Artal, Francisco Javier ; Rog, David

BACKGROUND:

The treatment landscape for relapsing multiple sclerosis (MS) has changed dramatically in recent decades, including an increasing number of high-efficacy disease-modifying therapies (DMTs) with varied administration and monitoring requirements. Coupled with greater focus on earlier treatment, these factors have resulted in stretching of the capacity of MS specialist services and allied healthcare professionals (HCPs). To assist with the effective planning of MS services in the UK NHS, this study quantified the administration and monitoring time burden associated with high-efficacy DMTs (alemtuzumab, cladribine tablets, fingolimod, natalizumab, and ocrelizumab) for relapsing MS.

METHODS:

A Time and Motion (T&M) study was conducted across four MS centres in the UK, over 3-4 months per centre (Aug 2019-Feb 2021). Time dedicated by HCPs (including but not limited to neurologists, MS specialist nurses, infusion nurses, and healthcare assistants) to pre-specified drug administration and monitoring activities, elicited during pre-study interviews at each centre, was assessed for each of the selected DMTs. Administration activities included: installing peripheral access; pre-medication administration (if needed); preparing drug for infusion; infusion initiation, monitoring, and disconnection; and patient monitoring post-infusion. Monitoring activities included: booking appointments for blood draws; blood draw; retrieval and review of blood results; maintaining blood records and follow-up with the patient; checking availability of MRI results and follow-up with the patient; booking appointments for neurologist or nurse consultations; and checking patient files prior to clinic visits. A T&M model was built using observational T&M study results, data obtained through pre-study interviews, as well as stipulated monitoring intervals from relevant Summaries of Product Characteristics for the selected DMTs, to estimate active HCP time with each DMT, extrapolated over a period of 4 years per-patient.

RESULTS:

For oral DMTs, projected total active HCP time (monitoring only) per-patient over 4 years was 14.7 h for cladribine tablets and 19.2 h for fingolimod. For infused DMTs, total time (administration and monitoring) for alemtuzumab was 37.7 h (6.0 and 31.6 h, respectively), 48.1 h for natalizumab (17.4 and 30.8 h, respectively), and 23.5 h for ocrelizumab (6.1 and 17.4 h, respectively).

CONCLUSIONS:

While active HCP time varied across centres, infused DMTs were projected to require the greatest amount of HCP time associated with administration and monitoring over 4 years versus oral DMTs. These findings may assist MS-specific HCPs in planning and delivering the equitable provision of DMT services for patients with relapsing MS.

01 Feb 2024·Multiple sclerosis and related disorders

Ocrelizumab in highly disabled progressive multiple sclerosis patients

Article

Author: Howard, Danielle ; Houtchens, Maria

BACKGROUND:

Ocrelizumab is a commonly used anti-CD20 monoclonal antibody with efficacy in the treatment of both relapsing-remitting (RRMS) and primary progressive (PPMS) multiple sclerosis. Real world use of ocrelizumab in MS patients with higher levels of motor disability requiring a walker or a wheelchair is not well characterized as these populations were excluded from initial studies. Higher levels of disability may be a barrier to treatment access. This study aimed to describe the access to, and tolerability and therapeutic outcomes of ocrelizumab in highly disabled MS patients in a real-world setting.

METHODS:

As part of an ongoing study of ocrelizumab treatment access, barriers, and outcomes in MS patients at the Brigham MS Center, we retrospectively reviewed all patients with an Expanded Disability Status Scale (EDSS) of 6.5 or greater at the time of ocrelizumab initiation. All patients were started on ocrelizumab by their treating providers prior to this study initiation. Patients were excluded for recent rituximab exposure, co-treatment with more than one immunosuppressant, or alternative diagnoses contributing to high EDSS. Data was collected on incidence and severity of side effects while on ocrelizumab, persistence of treatment beyond one year, and MS stabilization versus progression while on this treatment.

RESULTS:

Of the 1219 patients on ocrelizumab between 2017 and 2021, 113 (9.3 %) had EDSS of 6.5 or greater at the time of ocrelizumab initiation. Of the 113, 51 (45.1 %) were excluded: 6 (5.3 %) because they were duplicates or didn't receive ocrelizumab at our center, 25 (22.1 %) due to rituximab treatment in the previous year, 16 (14.2 %) due to lack of at least 1 year of follow up, and 4 (3.5 %) due to relevant comorbidities/treatment with other immunosuppressants. 62 patients were included in the final analysis. At ocrelizumab start, mean age was 62.1 +/- 8.7 years and median EDSS was 7.0 (range 6.5 to 9.5). Ocrelizumab was started in 26 of the included 62 patients (41.9 %) because of objective clinical disease worsening, in 17 (27.4 %) because of subjective worsening, in 8 (12.9 %) to prevent future progression. 32 patients (51.6 %) continued ocrelizumab throughout the study period, with average length of ocrelizumab use of 36.5 +/- 17.0 months. 29 patients (46.8 %) experienced no side effects during the study period. 29 (46.7 %) patients discontinued treatment, and of those, 9 (31.0 %) cited more than one reason for discontinuation: 17 (58.6 %) cited side effects, 12 (41.4 %) cited progression/lack of benefit, 6 (20.7 %) cited the Covid19 pandemic, and 1 (3.4 %) cited financial issues as a reason for discontinuation. Over the course of the study, 16 (25.8 %) patients had disability worsening by EDSS, 5 (8.1 %) had disability improvement, and 41 (66.1 %) remained stable, with a median end EDSS of 7.0 (range 6.5 to 9.5). Importantly, 18 patients (29.0 %) reported subjective disease stability while on ocrelizumab.

CONCLUSIONS:

Ocrelizumab may lead to disease stabilization in a subset of highly disabled MS patients, but possible benefits need to be carefully balanced against the incidence of adverse events in this high-risk patient population.

122

News (Medical) associated with Ocrelizumab

25 Jun 2024

·pipelinereview.com

Roche’s OCREVUS subcutaneous administration approved by European Commission, as first and only twice-a-year injection for relapsing and primary progressive multiple sclerosis

BASEL, Switzerland I June 25, 2024 I Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted marketing authorisation for OCREVUS® (ocrelizumab) subcutaneous (SC) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). OCREVUS SC is a 10-minute injection that maintains the same twice-yearly schedule as the previously approved intravenous (IV) infusion. More than 350,000 people with multiple sclerosis have been treated with OCREVUS IV globally. “OCREVUS transformed the way multiple sclerosis is treated as the first anti-CD20 therapy approved in this disease. Now, people in the EU with multiple sclerosis can have their medicine administered in just 10 minutes twice per year without needing an IV facility,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This makes it easier for more people with multiple sclerosis to access their treatment, while also saving time for providers.” The approval is based on pivotal data from the Phase III OCARINA II trial, which showed non-inferior levels of OCREVUS in the blood, when administered subcutaneously, and a safety and efficacy profile comparable to the IV formulation in patients with RMS and PPMS. OCREVUS SC was well tolerated and no new safety concerns were identified. More than 92% of patients who were surveyed as part of the study reported being satisfied or very satisfied with the SC administration of OCREVUS. OCREVUS SC was developed to provide an alternative twice-a-year treatment option, in addition to IV, so that the administration of OCREVUS can be matched to the individual needs of patients and healthcare professionals (HCPs). The SC injection was designed to be HCP administered, with the flexibility to administer either in the clinic or in settings outside the clinic. Roche is committed to advancing innovative clinical research programmes to broaden the scientific understanding of multiple sclerosis, further reduce disability progression in RMS and PPMS and improve the treatment experiences for those living with multiple sclerosis. About OCREVUS SC OCREVUS SC combines OCREVUS with Halozyme Therapeutics’ ENHANZE® drug delivery technology. OCREVUS is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. This nerve cell damage can lead to disability in people with multiple sclerosis. Based on preclinical studies, OCREVUS binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells, suggesting that important functions of the immune system may be preserved. The ENHANZE® drug delivery technology is based on a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily degrades hyaluronan – a glycosaminoglycan or chain of natural sugars in the body – in the subcutaneous space. This increases the permeability of the tissue under the skin, allowing space for OCREVUS to enter, and enabling it to be rapidly dispersed and absorbed into the bloodstream. OCREVUS is the first and only therapy approved for both RMS (including relapsing-remitting multiple sclerosis [RRMS] and active, or relapsing secondary progressive multiple sclerosis [SPMS], as well as clinically isolated syndrome [CIS] in the U.S.) and PPMS. About the OCARINA II study OCARINA II (NCT05232825) was a Phase III, global, multicentre, randomised study that evaluated the pharmacokinetics, safety and clinical and radiological efficacy of the subcutaneous (SC) formulation of OCREVUS compared with OCREVUS intravenous (IV) infusion in 236 patients with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). The trial met its primary and secondary endpoints, demonstrating SC injection was non-inferior to IV infusion based on OCREVUS levels in the blood, and comparable control of clinical (relapses) and radiological (MRI lesions) disease activity. The safety profile of OCREVUS SC was also consistent with the well-established safety profile of OCREVUS IV. About multiple sclerosis Multiple sclerosis is a chronic disease that affects more than 2.9 million people worldwide. Multiple sclerosis occurs when the immune system abnormally attacks the insulation and support around nerve cells (myelin sheath) in the central nervous system (brain, spinal cord and optic nerves), causing inflammation and consequent damage. This damage can cause a wide range of symptoms, including weakness, fatigue and difficulty seeing, and may eventually lead to disability. Most people with multiple sclerosis experience their first symptom between 20 and 40 years of age, making the disease the leading cause of non-traumatic disability in younger adults. People with all forms of multiple sclerosis experience disease progression – permanent loss of nerve cells in the central nervous system – from the beginning of their disease even if their symptoms aren’t apparent or don’t appear to be getting worse. Delays in diagnosis and treatment can negatively impact people with multiple sclerosis, in terms of their physical and mental health, and contribute to the negative financial impact on the individual and society. An important goal of treating multiple sclerosis is to slow, stop and ideally prevent progression as early as possible. Relapsing-remitting multiple sclerosis (RRMS) is the most common form of the disease and is characterised by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. Approximately 85% of people with multiple sclerosis are initially diagnosed with RRMS. The majority of people who are diagnosed with RRMS will eventually transition to secondary progressive multiple sclerosis (SPMS), in which they experience steadily worsening disability over time. Relapsing forms of multiple sclerosis (RMS) include people with RRMS and people with SPMS who continue to experience relapses. Primary progressive multiple sclerosis (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15% of people with multiple sclerosis are diagnosed with the primary progressive form of the disease. Until the FDA approval of OCREVUS, there had been no FDA-approved treatments for PPMS and OCREVUS is still the only approved treatment for PPMS. About Roche in Neuroscience Neuroscience is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases. Roche is investigating more than a dozen medicines for neurological disorders, including neuromuscular diseases: Duchenne muscular dystrophy, facioscapulohumeral muscular dystrophy and spinal muscular atrophy; neuro immune diseases: multiple sclerosis and neuromyelitis optica spectrum disorder; and neurodegenerative diseases: Alzheimer’s disease, Huntington’s disease and Parkinson’s disease. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the fifteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com . All trademarks used or mentioned in this release are protected by law. SOURCE: Roche

Clinical ResultPhase 3Drug Approval

25 Jun 2024

·www.prnewswire.com

Halozyme Announces Roche's OCREVUS® SC with ENHANZE® Receives European Commission Approval for Relapsing and Primary Progressive Multiple Sclerosis

OCREVUS® subcutaneous (SC) injection offers a new 10-minute administration with comparable efficacy and safety to intravenous (IV) infusion Provides an additional treatment option without the need for IV facilities, expanding accessibility for patients SAN DIEGO, June 25, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that Roche received European Commission (EC) marketing authorization of OCREVUS® (ocrelizumab) SC co-formulated with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). OCREVUS® SC is a 10-minute injection that maintains the same twice-yearly schedule as the approved IV infusion. The SC injection was designed to be administered by healthcare professionals, with the flexibility to be administered either in the clinic or in settings outside the clinic. "With OCREVUS SC, multiple sclerosis patients in the EU can now have their medicine administered in just 10 minutes, twice per year, and without the need for an IV facility," said Dr. Helen Torley, president and chief executive officer of Halozyme. "This creates enhanced flexibility for both patients and providers and represents another example of how Halozyme's breakthrough technologies help to create improved treatment options." The EC approval is based on pivotal data from the Phase III OCARINA II trial, which showed non-inferior levels of OCREVUS® in the blood, when administered subcutaneously, and a safety and efficacy profile comparable to the IV formulation in patients with RMS and PPMS. OCREVUS® SC was well tolerated, and no new safety concerns were identified. About Halozyme Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of reducing treatment burden for patients. Having touched more than 800,000 patient lives in post-marketing use in seven commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical and Acumen Pharmaceuticals. Halozyme also develops, manufactures and commercializes, for itself or with partners, drug-device combination products using its advanced auto-injector technologies that are designed to provide commercial or functional advantages such as improved convenience, reliability and tolerability, and enhanced patient comfort and adherence. The Company has two commercial proprietary products, Hylenex® and XYOSTED®, partnered commercial products and ongoing product development programs with several pharmaceutical companies including Teva Pharmaceuticals and Idorsia Pharmaceuticals. Halozyme is headquartered in San Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations facility. For more information visit and connect with us on LinkedIn and Twitter. Safe Harbor Statement In addition to historical information, the statements set forth in this press release include forward-looking statements including, without limitation, statements concerning the Company's ENHANZE® drug delivery technology including the possible benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, facilitating more rapid delivery and administration of higher volumes of injectable medications through subcutaneous delivery and certain other benefits of ENHANZE® including lowering the treatment burden for patients and alleviating pressure on health care system resources, including potential out-of-hospital administration of OCREVUS® SC. Forward-looking statements regarding the Company's ENHANZE® business may include potential growth driven by our partners' development and commercialization efforts (including anticipated regulatory submissions, PDUFA dates, potential regulatory approvals, indications and product launches). These forward-looking statements are typically, but not always, identified through use of the words "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning and involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Actual results could differ materially from the expectations contained in these forward-looking statements as a result of several factors, including unexpected results or delays in the growth of the Company's business, or in the development, regulatory review or commercialization of the Company's partnered products, regulatory approval requirements, unexpected adverse events or patient outcomes and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission. Except as required by law, the Company undertakes no duty to update forward-looking statements to reflect events after the date of this release. Contacts: Tram Bui VP, Investor Relations and Corporate Communications 609-359-3016 [email protected] Samantha Gaspar Teneo 212-886-9356 [email protected] SOURCE Halozyme Therapeutics, Inc.

Phase 3Drug ApprovalClinical Result

25 Jun 2024

·firstwordpharma.com

EU greenlights subcutaneous version of Roche’s Ocrevus to treat multiple sclerosis

The European Commission approved the subcutaneous (SC) formulation of Roche’s Ocrevus (ocrelizumab) to treat relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), maintaining the same twice-yearly dosing schedule as the intravenous (IV) version. The company noted Tuesday that the new formulation is intended to be administered by healthcare providers, either in the clinic or in other settings.“Now, people in the EU with multiple sclerosis can have their medicine administered in just 10 minutes twice per year without needing an IV facility,” making “it easier for more people…to access their treatment, while also saving time for providers,” said Levi Garraway, chief medical officer at Roche.The approval was backed by findings from the Phase III OCARINA II study, which showed that SC Ocrevus resulted in non-inferior blood levels, alongside a comparable safety and efficacy profile to the IV formulation. Moreover, over 92% of study participants surveyed reported being satisfied or very satisfied with the SC formulation.The SC version of the anti-CD20 antibody, which uses Halozyme's Enhanze drug delivery technology, is also awaiting a decision by the FDA in September. In a Firstword poll of US neurologists conducted last year, nearly a third of respondents said they would use SC Ocrevus exclusively over the IV version if approved, and half of those surveyed believed the Ocrevus franchise would gain a significant advantage over other anti-CD20 competitors such as Novartis’ Kesimpta (ofatumumab) and TG Therapeutics’ Briumvi (ublituximab).Ocrevus remains Roche’s top-selling drug, racking up CHF 6.4 billion ($7.1 billion) in global sales last year, with the EU accounting for nearly CHF 1.1 billion ($1.2 billion) of it.

Phase 3Clinical ResultDrug Approval

100 Deals associated with Ocrelizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D05218	Ocrelizumab	L04AA36	DB11988

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Multiple Sclerosis	AU	Roche Holding AG	13 Jul 2017
Multiple sclerosis relapse	US	Genentech, Inc.	28 Mar 2017
Multiple Sclerosis, Primary Progressive	US	Genentech, Inc.	28 Mar 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Multiple Sclerosis, Chronic Progressive	Phase 3	US	Hoffmann-La Roche, Inc.	28 May 2018
Multiple Sclerosis, Chronic Progressive	Phase 3	BA	Hoffmann-La Roche, Inc.	28 May 2018
Multiple Sclerosis, Chronic Progressive	Phase 3	BR	Hoffmann-La Roche, Inc.	28 May 2018
Multiple Sclerosis, Chronic Progressive	Phase 3	CA	Hoffmann-La Roche, Inc.	28 May 2018
Multiple Sclerosis, Chronic Progressive	Phase 3	CO	Hoffmann-La Roche, Inc.	28 May 2018
Multiple Sclerosis, Chronic Progressive	Phase 3	CR	Hoffmann-La Roche, Inc.	28 May 2018
Multiple Sclerosis, Chronic Progressive	Phase 3	CZ	Hoffmann-La Roche, Inc.	28 May 2018
Multiple Sclerosis, Chronic Progressive	Phase 3	DK	Hoffmann-La Roche, Inc.	28 May 2018
Multiple Sclerosis, Chronic Progressive	Phase 3	EG	Hoffmann-La Roche, Inc.	28 May 2018
Multiple Sclerosis, Chronic Progressive	Phase 3	FR	Hoffmann-La Roche, Inc.	28 May 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02688985 (CTgov)	Phase 3	Multiple Sclerosis, Primary Progressive \| Multiple sclerosis relapse	131	Antihistamine+Methyloprednisolone+ocrelizumab (RMS Cohort Arm 1: Ocrelizumab + LP)	ziyfwnsqco(anqyqleaao) = wihgzthdth vpeoxsstme (npkkuekmzc, teeasginpp - lgsoyrwuli) View more	-	04 Jun 2024
NCT02688985 (CTgov)	Phase 3		131	Antihistamine+Methyloprednisolone+ocrelizumab (RMS Cohort Arm 2: Ocrelizumab + LP)	ziyfwnsqco(anqyqleaao) = aqqwvrleof vpeoxsstme (npkkuekmzc, qlakbbuhcm - zwwxfsvxwn) View more	-	04 Jun 2024
NCT05232825 (OCARINA II, GlobeNewswire) Manual	Phase 3	Multiple Sclerosis	236	OCREVUS	dnxsjvczez(eqcqmnlbqv) = wsfizqzyno bymtqgywyr (qslqbtnshd ) View more	Positive	17 Apr 2024
ACTRIMS2024	Not Applicable	Multiple sclerosis relapse	69	Natalizumab	dztzynipkl(vztkwonewj) = afcwyimhdp lpiuupxmtw (yydpjhpryr ) View more	Positive	01 Mar 2024
ACTRIMS2024	Not Applicable	Multiple sclerosis relapse	69	Ocrelizumab	dztzynipkl(vztkwonewj) = lnyntedhro lpiuupxmtw (yydpjhpryr ) View more	Positive	01 Mar 2024
ACTRIMS2024	Not Applicable	-	-	Ocrelizumab	oifcfmktoa(hykgrdqdfo) = He experienced no infusion reaction, abdominal pain, or jaundice juihppuyoc (wesegqocvn )	-	29 Feb 2024
NCT04377555 (CHIMES, ACTRIMS2024)	Phase 4	Multiple sclerosis relapse	10	Ocrelizumab 300mg	evippnazox(bibeebdglz) = ighmflcerp ofgswedkuv (mzszhgabhg, 26.2 - 87.8) View more	Positive	29 Feb 2024
ACTRIMS2024	Not Applicable	Multiple Sclerosis, Primary Progressive	-	Ocrelizumab	gzekpiizar(igwnpndszc) = lqzibglmlh vutidlbuhg (opxatbqaak )	-	29 Feb 2024
ACTRIMS2024	Not Applicable	Multiple Sclerosis, Relapsing-Remitting	-	Ocrelizumab	eesdglvmut(dnxzfpjqua) = jmcciyjltm umyhvqjdco (cszwwgaiyq )	-	29 Feb 2024
NCT03972306 (OCARINA I, ECTRIMS2023)	Phase 1	Multiple Sclerosis	-	Ocrelizumab SC 920 mg	tgssvprdif(hyahdaetlz) = Injection site reactions were the most common adverse events, with erythema, pain and swelling being the most common symptoms, all of which were mild/moderate bqollardio (fmgwqsgrwb )	Positive	01 Oct 2023
NCT03972306 (OCARINA I, ECTRIMS2023)	Phase 1	Multiple Sclerosis	-	Ocrelizumab IV 600 mg		Positive	01 Oct 2023
ECTRIMS2023	Phase 3	Multiple Sclerosis	-	OCR-OCR	kgddgxpyki(lqzqaytska) = qvfwrdixcw aubtfwojhi (nahbydcgpp, 73.2 - 79.9) View more	-	30 Sep 2023
ECTRIMS2023	Not Applicable	Multiple Sclerosis, Relapsing-Remitting	-	Cladribine	yllyjfpjxg(tncqmqyzuk): HR = 1.08 (95% CI, 0.47 - 2.47)	-	30 Sep 2023
ECTRIMS2023	Not Applicable	Multiple Sclerosis, Relapsing-Remitting	-	Fingolimod	yllyjfpjxg(tncqmqyzuk): HR = 1.08 (95% CI, 0.47 - 2.47)	-	30 Sep 2023

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