Why Biogen/Eisai's Aducanumab Failure Is Not The End Of Amyloid Hypothesis
Biogen and Eisai still have multiple programs testing amyloid-targeting therapies in the treatment of Alzheimer's disease, but pressure for Biogen to focus its efforts elsewhere are mounting after the partners discontinued Phase III studies for aducanumab.
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Even analysts who still doubt the FDA will approve the anti-amyloid antibody as the first disease-modifying Alzheimer’s treatment said aducanumab’s likelihood of approval has improved.
In unusual move, FDA formed ‘working group’ collaboration with Biogen to conduct further analyses of two aducanumab studies after the Phase III trials were halted. Agency concluded drug’s effectiveness in one of the studies is ‘robust and exceptionally persuasive’ and advised Biogen that it was ‘reasonable’ to submit a marketing application.
Biogen's stock soared 44% after the US FDA released briefing documents for a high-profile advisory committee meeting to review aducanumab for Alzheimer's disease.