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VisitWhere will Eisai and Biogen submit their next major regulatory application for Leqembi by December 31, 2024?
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CHMP Recommends EU Rejection of Eisai and Biogen's Alzheimer's Drug Leqembi
Jul 26, 2024, 11:19 AM
On July 26, 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion on lecanemab, also known as Leqembi, an Alzheimer's therapy developed by Eisai and Biogen, recommending its rejection in the European Union. This decision diverges from the stance of U.S. regulators, who have approved the medicine. The rejection is a significant setback for Eisai and Biogen, who were seeking to expand sales of the drug in Europe.
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