Update on regulatory submission for Aducanumab to treat early Alzheimer's disease in the European Union.- Biogen.
Biogen Inc. has notified the European Medicines Agency (EMA) of its decision to withdraw its Marketing Authorization Application (MAA) for aducanumab for the treatment of the early stages of Alzheimer’s disease. The company withdrew its application following interactions with EMA’s Committee for Medicinal Products for Human Use (CHMP) indicating that the data provided thus far would not be sufficient to support a positive opinion on the marketing authorization of aducanumab by EMA.
Biogen’s MAA had been under review by the CHMP in response to the company’s request for a re-examination of the negative opinion the regulatory body issued in December 2021.
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