European drug authorities rejected Alzheimer's drug Leqembi on Friday Biogen And Eisaiwhich represents another hurdle for companies seeking to increase acceptance of the therapy in the US
The European Commission, the executive body of the European Union, has the final say on whether Leqembi should be approved, but it almost always follows the drug agency's recommendations.
Eisai said in a statement that it was “extremely disappointed” by the regulator's negative recommendation. The company added that it would seek a review of the decision.
Biogen shares fell more than 6 percent on Friday. Shares of Japanese pharmaceutical company Eisai remained virtually unchanged.
The U.S. Food and Drug Administration approved Leqembi last year, but its rollout has been slow due to bottlenecks in requirements for diagnostic tests and regular brain scans, among other issues. Leqembi has also received regulatory approval in other countries, including Japan, South Korea, China and Israel.
The drug was considered a breakthrough in a progressive disease that is notoriously difficult to treat. It is a monoclonal antibody that slows the progression of the disease in early-stage patients.
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The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended not granting marketing authorisation for Leqembi.
In a statement, the committee said that Leqembi's effect on delaying cognitive decline “does not outweigh the risk of serious side effects associated with the drug.” The committee specifically noted the “frequent occurrence” of brain swelling and bleeding in patients receiving the drug.
These side effects are associated with drugs such as Leqembi and another monoclonal antibody from Eli Lilly called Kisunla, which targets and eliminates a toxic plaque in the brain called amyloid, a hallmark of Alzheimer's disease. Kisunla was approved in the U.S. earlier this month.
Leqembi and Kisunla are milestones in the treatment of Alzheimer's disease after three decades of unsuccessful efforts to develop drugs to treat this deadly disease.
Another ill-fated drug from Biogen and Eisai called Aduhelm struggled to gain traction in the U.S. after doubts about its approval and data were raised. In 2021, the European Medicines Agency rejected Aduhelm.
Seven million people in Europe suffer from this mentally retarded disease, and that number is expected to double by 2050, according to the nonprofit organization Alzheimer's Europe.
