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Lecanemab was jointly developed by Eisai and Biogen. It was granted accelerated approval for medical use in the United States in January 2023, [7] and fully approved by the FDA in July 2023. [4] [8] Lecanemab was approved for medical use in South Korea in May 2024, [9] and in Mexico in December 2024. [10]
Lecanemab (a.k.a. leqembi) has received full approval from the U.S. Food and Drug Administration. This is the first FDA-approved treatment to help slow the progression of Alzheimer’s disease.
Lecanemab was jointly developed by Eisai and Biogen. It was granted accelerated approval for medical use in the United States in January 2023, [27] and fully approved by the FDA in July 2023. [24] [28] Lecanemab was approved for medical use in South Korea in May 2024, [29] and in Mexico in December 2024. [30]
The US FDA accepted Eisai’s Supplemental Biologics License Application (sBLA) for monthly LEQEMBI IV maintenance dosing in June 2024 and set a PDUFA action date for January 25, 2025. Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product ...
A: Lecanemab is the first new Alzheimer's drug with full approval in 20 years and is one of the first therapies that can slow the progression of Alzheimer’s disease — not just treat its symptoms.
A Prescription Drug User Fee Act (PDUFA) action date is August 31, 2025. The BLA is based on data from the Clarity AD (Study 301) open-label extension (OLE) and modeling of observed data.
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