March 26, 2020

The U.S. FDA has approved Zeposia® (ozanimod), manufactured by Bristoly-Myers Squibb, to treat relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It is the only drug in a class known as sphingosine-1-phosphate (S1P) receptor modulators that offers this patient population the chance for initiation with no genetic test and no label-based first-dose observation requirements.

Multiple sclerosis occurs when the body’s immune system attacks the myelin sheaths that cover and protect nerves. This damage creates lesions that interfere with the body’s ability to send signals through the nervous system. Two types of lesions—T1-weighted gadolinium-enhanced (GdE) brain lesions and T2 lesions—are used as markers of disease progression and severity. Most patients diagnosed with MS have a relapsing form, in which they experience periods of remission or symptom stability between episodes of worsening symptoms.

In clinical studies, Zeposia outperformed Avonex® (interferon beta-1a – Biogen), a current standard of care for relapsing MS. It delivered a relative reduction in annualized relapse rate versus treatment with Avonex of 48% through one year and 38% at two years. It also produced a 63% relative reduction in T1-weighted GdE brain lesions compared to Avonex, as well as a 48% relative reduction in the number of new or enlarging T2 lesions, in the first year of treatment. At two years of treatment, the relative reduction was 53% for T1-weighted GdE brain lesions and 42% for new or enlarging T2 lesions.

Recommended dosing requires titration for treatment initiation, building up to a maintenance dose of 0.92mg taken by mouth once a day. Prior to beginning treatment, patients should undergo assessment including a complete blood count, cardiac evaluation, liver function tests, ophthalmic assessment, review of current or prior medications, and testing for antibodies to varicella zoster virus.

Launch and pricing information are not yet available.

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