New Ocrevus Subcutaneous Injection Therapy Shows Promising Results in Multiple Sclerosis Treatmen

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New Ocrevus Subcutaneous Injection Therapy Shows Promising Results in Multiple Sclerosis Treatmen

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New Ocrevus Subcutaneous Injection Therapy Shows Promising Results in Multiple Sclerosis Treatmen

Treatment for this disease requires only two injections a year, almost completely preventing relapse! Positive results from Phase 3 of a new therapy.

Recently, Genentech, a subsidiary of Roche, announced positive data from the Phase 3 clinical trial OCARINA II of its flagship antibody therapy Ocrevus (ocrelizumab) in the treatment of relapsing or primary progressive multiple sclerosis (RMS or PPMS). The results show that the subcutaneous injection formulation of Ocrevus, requiring only two injections a year, almost completely suppressed clinical relapses and brain lesions. Regulatory submissions for the subcutaneous formulation of Ocrevus are currently under review by European and US regulatory authorities, with approval expected later this year.

Updated long-term follow-up results showed that the subcutaneous injection of Ocrevus (920 mg; n=236) almost completely suppressed relapse activity during the treatment phase (97.2% of patients had no relapses during treatment). The annual relapse rate on MRI at 48 weeks was 0.04, with the vast majority of patients having no Gd+T1 lesions and no new or enlarging T2 lesions, which are markers of active inflammation and disease burden, respectively. Furthermore, in exploratory patient-reported outcome measures, patients (n=52) reported high levels of satisfaction (92.3% of patients were satisfied or very satisfied) and convenience (90.1% of patients found it convenient or very convenient).

Additional data continues to show that the safety profile of the subcutaneous injection of Ocrevus is consistent with the established safety profile of intravenous Ocrevus. No new safety signals were identified. The most common adverse event in the subcutaneous injection group was injection reactions (occurring in 51.5% of all treated patients), including erythema (34.8%), pain (17.2%), swelling (9.4%), and itching (5.6%), all of which were mild or moderate and did not lead to treatment interruption.

The press release notes that this semi-annual, 10-minute subcutaneous injection has the potential to expand the use of Ocrevus in treatment centers without infusion facilities or limited infusion capacity. The European Medicines Agency (EMA) and the US FDA have accepted Genentech’s regulatory submissions, with EMA’s target decision date in mid-2024 and the FDA’s target decision date in September 2024.

Ocrevus is a humanized monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell believed to be a key factor in myelin and axonal damage. Over 300,000 patients worldwide have been treated with intravenous Ocrevus, which has been approved in more than 100 countries and regions.

New Ocrevus Subcutaneous Injection Therapy Shows Promising Results in Multiple Sclerosis Treatmen

References:

[1] Genentech’s Subcutaneous Ocrevus One-Year Data Demonstrates Near-Complete Suppression of Clinical Relapses and Brain Lesions in Patients With Progressive and Relapsing Forms of MS. Retrieved April 17, 2024

(source:internet, reference only)

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