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Lecanemab Conversion From Accelerated To Full Approval Could Be Among Fastest Ever

 
• By Bridget Silverman

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.

brain over the finish line
Lecanemab could be one of the fastest accelerated approvals to cross the full approval finish line. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

Biogen, Inc. and Eisai Co., Ltd. plan to submit an application for regular approval of lecanemab in early Alzheimer’s disease by the end of March 2023 based on the confirmatory Phase III CLARITY trial, shortly after the anti-amyloid beta protofibril antibody’s 6 January 2023 user fee goal date for accelerated approval.

The US FDA typically advises sponsors seeking accelerated approval to start their confirmatory studies as early as possible, but it is nonetheless unusual to see a confirmatory trial read out

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UroGen’s Mitomycin: Are Randomized Trials For Bladder Cancer Necessary?

 
• By Sue Sutter

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HHS Secretary Kennedy Says Trump Will Make Final Decision On Mifepristone Policy

 
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US FDA Adcomm To Consider If Genentech’s Columvi Study Generalizable To US

 
• By Sue Sutter

Patients from Asia saw a differential treatment effect versus non-Asian regions in the Phase III multiregional study, with an adverse survival trend seen in the latter group, the FDA said about the lymphoma drug.

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New EU Filings

 
• By Neena Brizmohun

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.