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News & Press: CMSC Industry News for MS (INforMS)

CMSC INforMS: Novartis gets FDA approval for Mayzent (siponimod), the first oral drug to treat SPMS

Friday, March 29, 2019   (0 Comments)
Posted by: Rachelle Ramirez
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EAST HANOVER, N.J., March 27, 2019 /PRNewswire/ --Novartis today announced that the US Food and Drug Administration (FDA) has approved Mayzent® (siponimod) for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome (CIS, is defined as a first episode of neurologic symptoms that lasts at least 24 hours and is caused by inflammation or demyelination in the central nervous system (CNS)3), relapsing remitting disease, and active secondary progressive disease, in adults. SPMS is a debilitating form of multiple sclerosis (MS) characterized by progressive and irreversible neurological disability4. Mayzent is expected to be available in the US in approximately one week.* Patients will not require a first dose observation (FDO, cardiac monitoring upon initiation) unless they have certain pre-existing cardiac conditions...[more]

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