Biogen Announces Positive CHMP Opinion For VUMERITY - Quick Facts

Biogen Inc. (BIIB) announced the Committee for Medicinal Products for Human Use has recommended granting marketing authorization for VUMERITY in the European Union. VUMERITY is a next-generation oral fumarate for the treatment of adults with relapsing-remitting multiple sclerosis.

The company said the positive CHMP opinion was based on data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA. The CHMP also assessed findings from EVOLVE-MS-2, a large, multi-center phase 3 study.

VUMERITY is an oral fumarate with a distinct chemical structure from TECFIDERA, approved in the U.S. for the treatment of relapsing forms of multiple sclerosis in adults.

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