Biogen Vumerity Receives Full US Approval, But GI Comparison With Tecfidera Must Wait

Label offers little differentiation from Tecfidera, but head-to-head trial with custom-designed patient-reported outcome could make case for gastrointestinal tolerability advantage.

US labeling for Biogen Inc. and Alkermes PLC’s Vumerity (diroximel fumarate) does not address the gastrointestinal tolerability advantage over Biogen’s Tecfidera (dimethyl fumarate) that the companies have long said is the rationale for developing the new multiple sclerosis therapy.

The Food and Drug Administration granted full approval to the Vumerity NDA on 29 October 2019, shortly after issuing a

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