Biogen pulls EU marketing application for Alzheimer’s drug
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Biogen (NASDAQ:BIIB) has decided to withdraw the Marketing Authorization Application (MAA) for its U.S.-approved Alzheimerâs therapy aducanumab in Europe, citing the inadequacy of data to support its regulatory recommendation in the region, the company said on Friday.
Biogen (BIIB) has informed the European Medicines Agency (EMA) of its decision after communications with the EMAâs Committee for Medicinal Products for Human Use (CHMP) indicated that the data would not support a positive opinion from the panel.
âWe stand by the safety and efficacy of aducanumab, and we look forward to upcoming data readouts to continue to provide important information on the science of this new class of compound,â Priya Singhal Biogenâs (BIIB) interim head of R&D said.
Last year, Biogen (BIIB) and its partner Eisai (OTCPK:ESALF) (OTCPK:ESALY) received the U.S. regulatory clearance for aducanumab under the accelerated approval pathway of the Food and Drug Administration (FDA).
The EU marketing application for the drug was under the review of CHMP after the company sought a reexamination of the negative opinion adopted by the panel in December.