FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Biogen’s Fampyra Awarded Standard Marketing Authorization in EU

May 30, 2017
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The European Commission has granted a standard marketing authorization for Fampyra for walking improvement in multiple sclerosis patients.

The full clearance was based on the results of a Phase 3 clinical study conducted following the EC’s conditional marketing authorization for Fampyra in 2011.

Biogen has a license from Acorda Therapeutics to commercialize Fampyra in markets outside the United States.

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