Eisai/Biogen’s Lecanemab Faces Smoother Passage Through US FDA Than Aducanumb
With amyloid plaque reduction established as a surrogate endpoint by Aduhelm’s accelerated approval for Alzheimer’s disease, lecanemab is unlikely to face an advisory committee before its 6 January user fee goal date.
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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.
Eisai To Shut Down H3 In Global R&D Restructuring
Eisai has decided to shut down its US oncology research operation H3 by September in the course of restructuring its global R&D organization. The majority of H3 employees will be laid off as Eisai Inc. and new organization DHBL absorb its functions and assets. Meanwhile another Japanese pharma firm, Astellas, builds up its US R&D footprint.
Will 2022 Be US FDA’s Year Of ‘No’? Approval Rate For Novel Agents Plunged In First Half
With 19 novel approvals and 14 complete response letters in the first half of 2022, the year is shaping up to be a turnabout from the big approval counts and rare CRLs of the recent approvals boom years.