By Colin Kellaher

Biogen and Eisai have hit another bump in their quest to win European regulatory approval of their Alzheimer's drug Leqembi.

The companies on Friday said the European Commission has asked the Committee for Medicinal Products for Human Use to consider information on the safety of the drug that became available after the panel finally adopted a positive opinion in November.

The commission wants the CHMP to consider whether the information may 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, the companies added.

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.

At the time, Biogen and Eisai said they expected the European Commission, which generally follows the CHMP's advice, to make a final decision within 67 days, but the companies on Friday said the CHMP will discuss the commission's requests at a meeting in February.

Biogen and Eisai said they believe that EC's requests can be addressed with existing information, and that no new safety signals have been identified for Leqembi.

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

January 31, 2025 07:14 ET (12:14 GMT)

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