Zeposia Is Now Approved, But Expect Delays

Zeposia’s recent approval in the U.S. is exciting news for all in the MS community. Unfortunately, we will need to table that excitement a bit longer. Despite its approval, the treatment’s commercial distribution will be delayed by the COVID-19 pandemic. I am confident, however, that it will be a game-changer once it’s readily available.

The Food and Drug Administration approved Zeposia (ozanimod) on March 25 to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting multiple sclerosis (RRMS), and active secondary progressive multiple sclerosis.

The European Medicines Agency is reviewing a marketing authorization application specifying ozanimod’s approval as a treatment for RRMS and is expected to make its ruling in the first half of 2020.

Zeposia is an oral medication taken once daily. An oral alternative to injections and infusions is alluring. While not the first oral disease-modifying therapy (DMT), the trend looks promising. Most oral DMTs are easier to administer and safer to tolerate for multiple subtypes of MS. It is vital to learn how each DMT works and how that might affect your overall health.

I thought of changing my own DMT when Mayzent (sipinomod) was approved in March 2019. My twice-annual infusions of Rituxan had become arduous. That said, I have remained on Rituxan without incident since 2015.

Zeposia is an oral sphingosine-1 phosphate (S1P) receptor modulator developed by Celgene (a subsidiary of Bristol-Myers Squibb). It works by limiting the number of lymphocytes from exiting the lymph nodes. Much like we are sequestered in our homes, so too are the lymphocytes in theirs: the lymph nodes. Limiting their presence in the peripheral blood and spinal cord reduces inflammation. While similar to Gilenya (fingolimod) and Mayzent in efficacy for relapsing MS, Zeposia may be superior in terms of safety.

“Because [Zeposia] is somewhat more selective for the receptors with which it interacts, this would reduce some of the safety issues that have been seen with fingolimod,” said Jeffrey Cohen, MD, a neurologist with the Cleveland Clinic’s Mellen Center for MS, in an interview with Multiple Sclerosis News Today.

“The main side effects that we’re seeing are very minor nasal pharyngitis, headache, side effects such as that,” he added. “The receptor selectivity and also the titration regimen at the initiation of therapy largely avoids the cardiac side effects, which are the big worry with other S1P modulators, so we think that’s a big advantage.”

Advantage, indeed. Once our world gets its arms around this coronavirus, Celgene will start mass marketing and distribution of Zeposia. Although I am not planning on taking it, I am eager to see its impact on the MS community.

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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.