European medicines regulator Friday reject Alzheimer’s disease treatment Leqembi Biogen and Eisaicreating another hurdle as companies scramble to increase adoption of the treatment in the U.S.
The European Commission, the EU’s executive arm, has the final say on Lekenby’s approval. But it almost always follows the recommendations of the drug regulator.
in a statementEisai said it was “extremely disappointed” with the regulator’s negative advice. The company added that it would seek to review the decision.
Biogen shares fell nearly 7% in pre-market trading on Friday. Shares of Japanese drugmaker Eisai were essentially flat.
The U.S. Food and Drug Administration approved Leqembi last year, but the drug’s rollout has been slow due to bottlenecks such as diagnostic testing requirements and regular brain scans. Leqembi has also received regulatory approval in other countries including Japan, South Korea, China and Israel.
The drug is considered a breakthrough in treating a progressive disease that is notoriously difficult to treat. It is a monoclonal antibody that slows the progression of a patient’s disease in its early stages.
The European Medicines Agency’s Human Medicinal Products Committee recommended against granting marketing authorization to Leqembi.
The committee said in a statement that Leqembi’s effect in slowing cognitive decline does not outweigh “the risk of serious side effects associated with the drug.” In particular, the committee noted that patients receiving treatment “frequently experienced” brain swelling and bleeding.
These side effects are associated with drugs such as Leqembi and another monoclonal antibody Eli Lilly and Company Kisunla works by targeting and removing toxic plaques in the brain called amyloid, which is a hallmark of Alzheimer’s disease. Kisunla was approved in the United States earlier this month.
Leqembi and Kisunla are landmarks in the treatment of Alzheimer’s disease, after three decades of failed efforts to develop drugs to combat the deadly disease.
Another ill-fated drug, Aduhelm, made by Biogen and Eisai, has struggled in the United States after its approval and data were questioned. In 2021, the European Medicines Agency rejected Aduhelm.
Seven million people in Europe live with the mind-consuming disease, a figure expected to double by 2050, according to the nonprofit Alzheimer’s Europe.
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