Roche announced on June 25 that the European Commission has granted OCREVUS (ocrelizumab) subcutaneous injection (SC) marketing authorization for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
The published clinical results show,Ocrevus Subcutaneous Injection, Requiring Only Two Doses per Year with Each Injection Taking Just 10 Minutes, Nearly Completely Suppresses Clinical Relapses and Brain Lesions.Ocrevus Subcutaneous Formulation Is Under FDA Review in the U.S., with Results Expected in September 2024.
Multiple SclerosisMultiple Sclerosis: A Chronic Disease Impacting Over 29 Million People GloballyMultiple sclerosis is a chronic disease that affects more than 29 million people worldwide. It occurs when the immune system abnormally attacks the insulating and supportive structures (myelin) surrounding nerve cells in the central nervous system (brain, spinal cord, and optic nerves), leading to inflammation and subsequent damage. This damage can cause a wide range of symptoms, including weakness, fatigue, and vision difficulties, and may eventually lead to disability. Most individuals with multiple sclerosis experience their first symptoms between the ages of 20 and 40, making it a leading cause of non-traumatic disability in young adults.
This approval is based on key data from the Phase III OCARINA II trial, which showedOcrevus Subcutaneous Injection FormulationDrug levels in the blood are comparable to those of intravenous formulations, and in patients with RMS and PPMSThe safety and efficacy in China are also consistent with intravenous injection.The long-term follow-up results published in April this year showed that Ocrevus subcutaneous injection (920 mg; n=236) almost completely suppressed relapse activity during the treatment period (97.2% of patients did not experience a relapse during treatment).The annual relapse rate at 48 weeks of magnetic resonance imaging (MRI) was 0.04, with the vast majority of patients showing no Gd+T1 lesions and no new/enlarging T2 lesions. These lesion types are markers of active inflammation and disease burden, respectively.Ocrevus® SCWell tolerated, with no new safety issues identified. Over 92% of patients participating in the study expressed satisfaction or strong satisfaction with the administration method of Ocrevus® SC.Ocrevus®It is a humanized monoclonal antibody designed to target CD20-positive B cells—a specific type of immune cell considered a key factor in causing damage to myelin (the insulation and support for nerve cells) and axons (nerve cells). This nerve cell damage can lead to disability in patients with multiple sclerosis.Based on preclinical studies, Ocrevus®Binds to the CD20 cell surface protein expressed on certain B cells, but not on stem cells or plasma cells, suggesting that important functions of the immune system may be preserved.Ocrevus® SC Combined with Ocrevus®ENHANZE by Halozyme Therapeutics®Drug Delivery Technology.ENHANZE®The drug delivery technology is based on proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that locally and temporarily degrades hyaluronic acid (glycosaminoglycan or natural sugar chains in the body) in the subcutaneous space. This technology increases the permeability of the tissue beneath the skin, providing space for Ocrevus® to enter, allowing it to disperse quickly and be absorbed into the bloodstream.Ocrevus®It is the first and only therapy approved for the treatment of multiple sclerosis, including relapsing-remitting multiple sclerosis (RRMS), active or relapsing secondary progressive multiple sclerosis (SPMS), clinically isolated syndrome (CIS) in the United States, and primary progressive multiple sclerosis (PPMS).OCREVUS, as the first approved anti-CD20 therapy for this condition, has revolutionized the treatment of multiple sclerosis. Its convenient treatment approach allows more MS patients to receive therapy easily, while also significantly reducing the burden on healthcare providers. We look forward to Roche continuing to innovate in the future.Advance innovative clinical research projects to further reduce disability progression in RMS and PPMS, and improve the treatment experience for patients with multiple sclerosis.
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