Fierce Biotech March 12, 2024
Ever since the controversial approval of Biogen and Eisai’s Aduhelm, debate has swirled around the strength of the link between amyloid reduction and the cognitive benefits of potential Alzheimer’s disease treatments. The FDA appears to have stepped back into this arena as part of fresh updates to its guidance on these drugs.
The agency isn’t going as far as to say that amyloid reduction can be considered a primary endpoint in Alzheimer’s trials, but the regulator is suggesting that the biomarker can serve as a surrogate endpoint for predicting clinical benefit, according to the draft guidelines released (PDF) March 11. Stakeholders can submit comments to the FDA regarding the new guidelines by June 10.
The guidance, titled “Early Alzheimer’s...
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