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
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| Ref: PRNewswire | Image: Biogen
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