Columns The MS Wire - A Column by Ed Tobias FDA Approval of Investigational DMT Ozanimod May Be Weeks Away FDA Approval of Investigational DMT Ozanimod May Be Weeks Away by Ed Tobias | March 6, 2020 Share this article: Share article via email Copy article link By the end of this month, another disease-modifying therapy (DMT) for multiple sclerosis may be available in the U.S. Ozanimod is an investigational daily pill for the treatment of relapsing MS. The Food and Drug Administration is expected to decide whether to approve ozanimod by March 25. Approval was expected about a year ago, but the FDA kicked back the original application to ozanimod’s manufacturer, Celgene, a subsidiary of Bristol-Myers Squibb, asking for more information. Celgene resubmitted the application in June 2019. Ozanimod is an immunomodulator, meaning it modifies the immune system. In this case, the medication is designed to prevent immune cells from entering the brain and causing inflammation there and in the spinal cord. It’s in the same class of treatments as Gilenya (fingolimod) and Mayzent (siponimod), both of which are approved by the FDA. Celgene said that ozanimod is expected to have a better safety profile and fewer side effects than those treatments, possibly because it reduces some, but not all, of the white cells circulating in the blood. Ozanimod’s test results have been good In a Phase 3 clinical trial, those treated with ozanimod had fewer relapses and brain lesions than others treated with Avonex (interferon beta-1a). They also showed improved cognitive processing speed. In a separateĀ Phase 2/3 trial, those treated with ozanimod had fewer brain lesions and relapses than those given a placebo. In an extension of that trial, in which members of the placebo group joined the others in taking the medication, brain MRIs showed no evidence of active inflammation or disease activity in more than 86 percent of the patients. The European Medicines Agency also is reviewing ozanimod, with a decision likely in the first half of this year. In a June 2019 news releaseĀ when the treatment was resubmitted for approval to both the EMA and the FDA, Celgene’s chief medical officer, Jay Backstrom, said, āWe believe that ozanimod has the potential to be an important option early in the treatment of relapsing forms of MS and a best-in-class S1P receptor modulator.ā Where are the DMTs for progressive MS? It’s wonderful that another disease-modifying therapy may be on the verge of approval for MS. Three other DMTs are in late-phase clinical trials: laquinimod, ublituximab, and ponesimod. But of those, only laquinimod is intended for a progressive form of MS ā primary progressive ā as well as the relapsing form. As I’ve asked before, why aren’t pharmaceutical companies producing more MS treatments indicated for the progressive forms? I welcome your comments below or in our MS News Today Forums. You’re also invited to visit my personal blog at www.themswire.com. *** Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to multiple sclerosis. Print This Page About the Author Ed Tobias People say to write what you know and Ed Tobias knows about MS. He's lived with the illness since 1980, when he was 32 years old. Ed's a retired, award-winning broadcast journalist and his column combines his four decades of MS experiences with news and comments about the latest in the MS community. In addition to writing his column, Ed is one of the patient moderators on the MS News Today Facebook, Twitter, and Instagram sites. Heās also the author of āThe Multiple Sclerosis Toolbox: Hints and Tips for Living with M.S.ā Ed and his wife split their time between the Washington, D.C. suburbs and Floridaās Gulf Coast, trying to follow the sun. Tags Avonex (interferon beta1-a), Bristol Myers Squibb, Celgene, clinical trials, DMTs, Gilenya (fingolimod), Mayzent (siponimod), Ozanimod Comments Mark Collins Still say kill ebv in human body maybe some improvement will start Reply Jayne Mason What is ebv in the human body ??? Reply Ed Tobias Jayne, Epstein-Barr Virus. There may be a relationship between it and MS. Ed Reply Leave a comment Fill in the required fields to post. Your email address will not be published. Your Name Your Email Your Comment Post Comment
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