Leqembi’s application now moves forward to the European Commission, which will issue a formal verdict for the injection that will apply to all EU member states as well as Norway, Liechtenstein and Iceland.
Biogen and Eisai move one step closer to the European approval of the Alzheimer’s disease therapy Leqembi after a key regulatory body issued a positive recommendation for the drug’s approval in the European Union.
The Committee for Medicinal Products for Human Use (CHMP), which prepares the European Medicines Agency’s opinion about medical drugs for human use, said on Friday that its prior recommendation for Leqembi “does not need to be updated.”
The CHMP in November 2024 backed the use of Leqembi for the treatment of adults with mild cognitive impairment or mild dementia in connection with Alzheimer’s disease (AD)—but only in those with only one or no copy of the ApoE4 genetic alternation. At the time, the CHMP noted that in this restricted population, “the benefits of Leqembi in slowing down progression of symptoms of the disease are greater than its risks.”
Then in January 2025, the European Commission, which is the primary executive arm of the European Union, asked the CHMP to revisit its recommendation, saying that new information regarding the drug’s safety had become available since the initial positive opinion.
But in its announcement on Friday, the CHMP noted that these new safety findings do not change its initial opinion, and that it stands by its recommendation for a marketing authorization for Leqembi. The matter now moves forward to the European Commission (EC), which will have the final say over whether Leqembi (lecanemab) will be approved or not.
The Commission’s verdict will apply to all 27 member states of the European Union plus Norway, Liechtenstein and Iceland, according to a Friday press announcement from Biogen and Eisai. If approved, the partners will “make every effort to deliver lecanemab to patients with early AD in Europe as soon as possible.”
Leqembi’s European approval could give the drug’s sales a much-needed boost. Since its accelerated approval in the United States in January 2023—and full approval there in July of the same year—Leqembi has consistently returned disappointing figures. In November 2024, for instance, Eisai was forced to lower its 2024 fiscal year guidance for Leqembi, bogged down by a slow launch and roadblocks to access.
Still, things seem to be looking up for the anti-amyloid antibody, with Eisai last month posting approximately $87.4 million in third-quarter sales of the drug—around $51 million of which came from the U.S.—topping analyst expectations. Eisai and Biogen are also developing a subcutaneous formulation of the drug, which could “reduce burden on healthcare professionals and patients” by allowing home treatments and lowering hospital visits, according to an Eisai presentation.
