Eisai/Biogen Maintain Lead Over Lilly In New Race To Alzheimer’s Approval
Full Approval Filing May Quickly Follow Accelerated US FDA Decision
The US FDA accepted an application for accelerated approval and set a 6 January action date, giving lecanemab ample time to reach the market ahead of Lilly’s competing anti-amyloid antibody donanemab.
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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.
In addition to its uncertain attempt at near-term revenue growth with Eisai-partnered lecanemab, Biogen recently ended multiple R&D programs and will pay $900m to settle a whistleblower lawsuit.
Lilly believes its approach can help identify the Alzheimer’s patients who would benefit most from a beta amyloid clearing therapy – but skepticism about the mechanism itself remains widespread.