Biogen and Alkermes’ Vumerity (diroximel fumarate) Receive FDA’s Approval for Multiple Sclerosis

Biogen and Alkermes’ Vumerity (diroximel fumarate) Receive FDA’s Approval for Multiple Sclerosis

Shots:

  • The FDA’s approval is based on NDA submitted under the 505(b)(2) filing pathway and contain data from P-III EVOLVE-MS-1 study assessing Vumerity in patients with relapsing-remitting MS
  • In Nov’2017, Biogen and Alkermes collaborated to develop & commercialize Vumerity under which Alkermes to receive $150M and royalties on WW sales of Vumerity for the 5yrs. following the US FDA’s approval
  • VUMERITY is novel fumarate referencing Tecfidera (dimethyl fumarate) with a distinct chemical structure and is approved in the US to treat relapsing MS, being evaluated for improved patient-reported gastrointestinal tolerability

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Cen.acs