Roche Submits Regulatory Applications for Ocrevus (ocrelizumab) with Shortened 2-Hour Infusion Time, Maintaining Twice-Yearly Dosing for Multiple Sclerosis
Apr 21, 2020 16:32
CST Updated
16:32
Roche
Oncology Drug Research, Development, and Manufacturing
Genentech
Pharmaceutical R&D Manufacturer
April 21, 2020 News /BioValleyBIOON/ --- Roche recently announced that regulatory applications for its multiple sclerosis drug Ocrevus (ocrelizumab) have been accepted by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively. The applications pertain to a 2-hour infusion regimen of Ocrevus, administered twice yearly for the treatment of patients with relapsing forms of multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS).FDAand the EMA is expected to make an approval decision by the end of 2020. If approved, the infusion time for Ocrevus will be reduced from the current3.5 hours reduced to 2 hours。
Ocrevus was first approved in the United States in March 2017FDAApproved for market launch, it has been approved in 90 countries worldwide to date. This drug isThe first and only approved treatment for RMS (including relapsing-remitting MS [RRMS], active or relapsing secondary progressive MS [SPMS], and clinically isolated syndrome [US market]) and primary progressive multiple sclerosis (PPMS).This drugAdministered via intravenous infusion every 6 months, requiring only 2 infusions per year., which can significantly improve patients' treatment adherence. Real-world experience with Ocrevus is rapidly increasing, with over 150,000 patients worldwide having received treatment with this drug.
This regulatory submission is based on data from the randomized, double-blind ENSEMBLE PLUS study. The study demonstrated that in patients with relapsing-remitting multiple sclerosis (RRMS),The 2-hour Ocrevus infusion regimen demonstrates a safety profile consistent with that of the currently approved 3.5-hour infusion regimen., the two regimens were comparable in terms of the frequency and severity of infusion-related reactions (IRRs). In this study, no patients discontinued the study due to IRRs, and no new safety signals were detected. The data from this study will be presented at future medicalMeetingpublished above.
Dr. Levi Garraway, Chief Medical Officer and Global Head of Product Development at Roche, stated: “To date, more than 150,000 individuals have been treated with Ocrevus. The drug’s twice-yearly dosing regimen has benefited many patients with multiple sclerosis (MS) and their physicians, with over 90% of patients continuing treatment for one year. We hope that the shorter infusion time will further enhance the experience of MS patients while also increasing the capacity of healthcare systems.”
Multiple Sclerosis (MS) is a chronic inflammatory, demyelinating disease of the central nervous system that affects approximately 2.3 million people worldwide, with no curative medication currently available. MS occurs when the body’s immune system abnormally attacks the myelin—the insulating layer and supportive structure surrounding nerve cells—in the brain, spinal cord, and optic nerves, causing inflammation and associated damage. This damage can lead to a range of symptoms, including visual impairment, muscle weakness, speech difficulties, severe fatigue, and cognitive dysfunction; in severe cases, it can result in mobility impairment and disability. The average age of onset for multiple sclerosis is typically between 20 and 40 years, making it a leading cause of non-traumatic disability among young adults.
Ocrevus is a humanized monoclonal antibody that selectively targets CD20-positive B cells, a specific type of immune cell considered to be a key factor in causing myelin and axonal damage, which can lead to disability in patients with multiple sclerosis (MS). Preclinical studies have confirmed that Ocrevus selectively binds to the CD20 cell surface protein expressed on specific B cells, but does not bindStem Cellsand the CD20 protein on the surface of plasma cells, thereby preserving important functions of the immune system. (Bioon.com)