Morningstar

Biogen, Eisai Get FDA Approval for Injectable Alzheimer's Treatment

Provided by Dow Jones Aug 29, 2025, 9:55:00 PM

By Dean Seal

Biogen and Eisai said federal regulators have approved a once-weekly injectable version of their Alzheimer's treatment Leqembi.

The Food and Drug Administration's approval will allow the Leqembi Iqlik autoinjector to be launched in the U.S. on Oct. 6.

The jab is intended for Alzheimer's disease patients with mild cognitive impairment or mild dementia stage of disease.

After 18 months of traditional intravenous Leqembi treatment every two weeks, patients can now either continue with the IV infusions every four weeks or start using Leqembi Iqlik each week.

The FDA first approved Leqembi in 2023. It has since been approved in the U.K., Japan, China and other countries.

Biogen shares rose 1% to $133.50 after hours.

Write to Dean Seal at dean.seal@wsj.com

(END) Dow Jones Newswires

August 29, 2025 17:55 ET (21:55 GMT)

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