In a setback for Biogen and Eisai, European drug regulators have rejected their Alzheimer’s treatment, Leqembi. The decision adds another challenge for the companies as they work to increase the drug’s use in the U.S. and other markets.
The European Medicines Agency’s human medicines committee concluded that Leqembi’s benefits in delaying cognitive decline do not outweigh the serious side effects associated with the treatment. These include frequent occurrences of brain swelling and bleeding, which raised significant safety concerns.
Leqembi, a monoclonal antibody, was hailed as a breakthrough in the treatment of Alzheimer’s, a disease that has been notoriously difficult to address. It targets and clears amyloid plaques in the brain, which are characteristic of Alzheimer’s. Despite its potential, the European regulators were not convinced that the drug’s benefits justified the risks.
Eisai expressed deep disappointment in the decision and plans to request a reexamination. The European Commission, which usually follows the regulator’s advice, will make the final decision on Leqembi’s approval.
Shares of Biogen fell over 6% following the news, while Eisai’s stock remained relatively stable. The U.S. FDA had already approved Leqembi, though its uptake has been slow due to various challenges, including diagnostic requirements and regular brain scans. The drug has also been approved in other countries, including Japan, South Korea, China, and Israel.
The rejection in Europe mirrors a similar outcome for another Biogen and Eisai Alzheimer’s drug, Aduhelm, which was not approved by European regulators in 2021. Both Leqembi and Aduhelm have faced scrutiny over their effectiveness and safety, reflecting the broader challenges in developing effective treatments for Alzheimer’s.
The decision affects millions in Europe suffering from Alzheimer’s, with the number of patients expected to double by 2050. As Biogen and Eisai navigate these regulatory hurdles, the search for effective Alzheimer’s treatments continues to be a critical area of medical research and development.
