By Colin Kellaher
A key European regulatory panel has reversed course and is now recommending approval of Leqembi, the Alzheimer's drug from Biogen and Eisai.
The companies on Thursday said the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion on the drug after a re-examination of its earlier negative stance.
The CHMP in July recommended against approval of Leqembi, citing safety and efficacy issues, but Biogen and Eisai asked the panel to take another look.
The companies said the European Commission which generally follows the CHMP's advice, is expected to make a final decision within 67 days
The U.S. Food and Drug Administration last year approved Leqembi, which also is 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.
The drug generated third-quarter sales of about $67 million, including $39 million in the U.S.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
November 14, 2024 11:59 ET (16:59 GMT)
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