FDA approves Vumerity to treat relapsing forms of MS

Pharmaceutical Technology | October 31, 2019

The US Food and Drug Administration (FDA) has approved Biogen and Alkermes’ oral drug Vumerity (diroximel fumarate) to treat relapsing forms of multiple sclerosis (MS). Biogen holds the exclusive licence to commercialise the drug globally and intends to make it available in the US in the coming days. Biogen chief medical officer and research and development executive vice-president Alfred Sandrock said: “The FDA’s approval of Vumerity delivers on Biogen’s commitment to pursue new therapies that may provide meaningful impact for people living with relapsing MS and we look forward to bringing it to the MS community as an additional treatment option. “Vumerity is a novel fumarate that offers the well-characterised efficacy of Tecfidera (dimethyl fumarate) and has been studied for improved patient-reported gastrointestinal tolerability.” FDA approved the drug based on a new drug application (NDA) submitted under the 505(b)(2) filing pathway. The submission also included interim exposure and safety findings from an ongoing, Phase III, single-arm, open-label, two-year safety trial EVOLVE-MS-1 evaluating Vumerity in patients with relapsing-remitting MS.

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