Pharmaceutical company Eisai, a partner of Swedish company Bioarctic, is targeting U.S. approval in fiscal year 2025 for a domestic version of the Alzheimer’s drug Leqembi.
The new injectable pen version is intended for patients who have completed the initial treatment phase and could reduce the number of hospital visits. The FDA is expected to make a decision by August 31, 2025, and after the US launch, a launch in China and India is planned. Eisai is developing the drug in collaboration with Biogen and Bioarctic.
According to Haruo Naito, CEO of Eisai, the new formulation will revolutionize the treatment of Alzheimer’s disease.
-Leqembi is already approved in the United States for the treatment of mild cognitive impairment and mild Alzheimer’s disease. It has also been authorized in several other countries.
Health
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