Eisai, Biogen Get FDA Approval for Treatment for Early Alzheimer's Disease
By Kelly Cloonan
Eisai and Biogen won approval from the Food and Drug Administration for an injection of their Leqembi Iqlik drug as an initiation dose to treat early Alzheimer's disease.
The companies said Monday the drug is administered via an autoinjector, offering an alternative to intravenous dosing.
For initiation, the drug is approved to be given once weekly as two 250 milligram injections. It may also be used for maintenance dosing at 360 milligrams once weekly after 18 months of IV or subcutaneous treatment, the companies said.
The drug is indicated in the U.S. for adults with mild cognitive impairment or mild dementia due to Alzheimer's disease, which are collectively referred to as early Alzheimer's disease.
Eisai leads the development and regulatory submissions for the drug globally. Eisai and Biogen co-commercialize and co-promote the product.
Write to Kelly Cloonan at kelly.cloonan@wsj.com
(END) Dow Jones Newswires
July 13, 2026 18:14 ET (22:14 GMT)
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