Another Blow To Aduhelm As Biogen Withdraws EU Filing
Adds To US Commercial Failure
Biogen has withdrawn its filing of the Alzheimer’s drug before the EMA could reject it for the second time, perhaps hoping it could return with better data.
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Biogen’s biosimilars business took a hit in Q1 following pricing pressures and negative currency fluctuations, with the company now prioritizing the rebuilding of the segment.
Lecanemab is now filed for accelerated approval with the US FDA, but the wait for a Phase III readout could impact the hunt for Biogen’s next CEO.
Aduhelm commercialization was a bust, so Biogen’s next big hope for a potential blockbuster Alzheimer’s therapy is partner Eisai’s amyloid protofibril-targeting antibody lecanemab.