Drug Approvals

Merck KGaA gets FDA nod for MS med

Mar 31, 2019

 The U.S. FDA has approved EMD Serono's — Merck KGaA's biopharma unit — Mavenclad tablets for the treatment of relapsing forms of multiple sclerosis.

Mavenclad offers a new way to treat MS – short treatment courses with pills taken for no more than 10 days in a year and no injections or infusions.

The drug was fast tracked by the FDA 13 years ago and at the time, was racing Novartis’ Gilenya to market (the Novartis drug hit the market in 2010).

According to the drugmaker, Mavenclad is the first and only FDA-approved treatment for relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS) that provides two years of proven efficacy with a maximum of 20 days of oral treatment, during a two-year period.

Read the press release.

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