European Medicines Agency on Friday rejected the Alzheimer treatment Leqembi from Biogen And Eisaiwhich represents one other hurdle for firms in search of to extend acceptance of the therapy within the US
The European Commission, the EU's executive body, has the ultimate say on whether Leqembi must be approved, but it surely almost all the time follows the drug agency's recommendations.
In a opinionEisai said it was “extremely disappointed” by the regulator's negative advice. The company added that it could seek a review of the choice.
Biogen shares fell nearly 7 percent in premarket trading on Friday. Shares of Japanese pharmaceutical company Eisai remained virtually unchanged.
The U.S. Food and Drug Administration approved Leqembi last yr, but its rollout has been slow because of bottlenecks in requirements for diagnostic tests and regular brain scans, amongst 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’s notoriously difficult to treat. It is a monoclonal antibody that slows the progression of the disease in early-stage patients.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has really useful not granting marketing authorisation for Leqembi.
In a press release, 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 unintended effects are related to drugs similar to Leqembi and one other monoclonal antibody from Eli Lilly called Kisunla, which targets and eliminates a toxic plaque within the brain called amyloid, a trademark of Alzheimer's disease. Kisunla was approved within the U.S. earlier this month.
Leqembi and Kisunla are milestones within the treatment of Alzheimer's disease after three many years of unsuccessful efforts to develop drugs to treat this deadly disease.
Another ill-fated drug from Biogen and Eisai called Aduhelm struggled to achieve traction within 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 anticipated to double by 2050, in line with the nonprofit organization Alzheimer's Europe.
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