Sunday, January 8, 2023

Alzheimer’s Drug From Eisai, Biogen Gets FDA Accelerated Approval

AlzheimersLate last week, the U.S. Food and Drug Administration gave accelerated approval to the Alzheimer’s drug lecanemab, developed by Eisai Co. and Biogen Inc. The drug will be sold under the brand Leqembi and will run about $26,500 for a year’s supply. 

Lecanemab aims to slow the advance of neurodegenerative disease by removing toxic protein beta amyloid from the brain. Eisai estimated that approximately 100,000 patients will be eligible for the drug within the next three years. “Our assumption is that the number of global patients eligible for the drug will grow to around 2.5 million by around 2030,” Eisai CEO Haruo Naito told reporters.

The next step is to receive traditional FDA approval. Eisai officials plan to submit data from a recent successful clinical trial for full review.

For more information see Fiona Rutherford and Robert Langreth “Alzheimer’s Drug From Eisai, Biogen Gets FDA Accelerated Approval, Bloomberg, January 7, 2023.

Special thanks to Lewis Saret (Attorney, Washington, D.C.) for bringing this article to my attention. 

https://lawprofessors.typepad.com/trusts_estates_prof/2023/01/alzheimers-drug-from-eisai-biogen-gets-fda-accelerated-approval.html

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