www.fdanews.com/articles/181939-biogens-fampyra-awarded-standard-marketing-authorization-in-eu
Biogen’s Fampyra Awarded Standard Marketing Authorization in EU
May 29, 2017
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.