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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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.
Given inconsistent study results, robustness of the efficacy evidence is expected to be key focus of the 6 November meeting of the Peripheral and Central Nervous System Drugs Advisory Committee; review could put a December 2019 guidance on the ‘substantial evidence’ standard to the test and offer insight into the amount of flexibility the agency is willing to exercise for neurodegenerative diseases with high unmet need.