By Colin Kellaher

Biogen and Eisai said the European Medicines Agency's Committee for Medicinal Products for Human Use has reaffirmed its recommended approval of their Alzheimer's drug Leqembi.

The companies on Friday said the European Commission, which had asked the panel to consider information on the safety of Leqembi that became available after it adopted a positive opinion in November, will resume its decision-making process for the drug's marketing authorization.

The commission last month asked the CHMP to consider whether the new information would require an update of the positive opinion, and to consider whether the wording of the risk minimization measures in the opinion is clear enough to ensure correct implementation.

Biogen and Eisai on Friday said the CHMP concluded that its positive opinion didn't need to be updated.

The CHMP last July recommended against approval of Leqembi, citing safety and efficacy issues, but Biogen and Eisai asked the panel to take another look, and the CHMP in November reversed course and recommended approving the drug.

The U.S. Food and Drug Administration in 2023 approved Leqembi, which is also approved in the U.K., Japan, China and several other countries.

Japan's Eisai serves as the lead for Leqembi's development and regulatory submissions worldwide and co-commercializes the drug with Cambridge, Mass., biotechnology company Biogen.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

February 28, 2025 09:52 ET (14:52 GMT)

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