Biogen/Eisai’s Lecanemab Suggests A New Model For Accelerated Approval In The US
Why not wait for the confirmatory trial to read out before approval, at least in the context of an especially uncertain or controversial surrogate marker?
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Lecanemab Conversion From Accelerated To Full Approval Could Be Among Fastest Ever
Biogen/Eisai’s Phase III data is on track for a Q1 2023 submission, potentially just weeks after lecanemab is expected to gain accelerated approval for early Alzheimer’s.
How Biogen’s Aduhelm Bet Became A Commercial Bust
Biogen caught a lucky break in getting the first FDA approval for a potentially disease-modifying Alzheimer’s therapy, but doubt over clinical benefit and commercial missteps have left Biogen in a precarious position a year later.
Lilly Phase III Alzheimer’s Data Will Set Stage For Unrestricted Medicare Coverage Request
Donanemab results due next year have a good chance of persuading CMS to offer unrestricted coverage, Lilly argues, even though the drug might just have accelerated approval at that point. ‘We believe that having two positive pivotal trials should meet that high level of evidence.’