European drug regulators on Friday discarded object Alzheimer’s disease treatment Leqembi from Biology And Eisaicreating another barrier for companies as they struggle to enhanced absorption of therapy in the United States
The European Commission, the EU’s executive body, has the final say in approving Leqembi. But it almost always follows the recommendations of the drug regulator.
In one declareEisai said it was “extremely disappointed” by the regulator’s negative recommendation. The company added that it would seek a review of the decision.
Shares of Biogen fell nearly 5% on Friday. Shares of Japanese pharmaceutical company Eisai were essentially flat.
The US Food and Drug Administration last year approved Leqembi, which has seen a slow rollout due to hurdles related to requiring diagnostic testing and frequent brain scans, among other issues, has also won regulatory approval in other countries such as Japan, South Korea, China and Israel.
The drug is seen as a breakthrough for a progressive disease that has proven difficult to treat. It is a monoclonal antibody that slows the progression of the disease in patients in its early stages.
The European Medicines Agency’s human medicinal products committee has recommended against granting marketing authorisation to Leqembi.
In a statement, the committee said Leqembi’s effectiveness in slowing cognitive decline did not outweigh the “risk of serious adverse events associated with the drug.” The committee specifically pointed to “frequent occurrences” of brain swelling and bleeding in patients treated with the drug.
Those side effects have been linked to drugs like Leqembi and another monoclonal antibody from Eli Lilly called Kisunla, works by targeting and removing toxic plaque in the brain called amyloid, a hallmark of Alzheimer’s disease. Kisunla has won approval in the United States in the first day of this month.
Leqembi and Kisunla are milestones in the treatment of Alzheimer’s after three decades of unsuccessful attempts to develop drugs that can combat the deadly disease.
Another ill-fated drug from Biogen and Eisai, called Aduhelm, struggled to get off the ground in the U.S. after questions about its approval and data. In 2021, the European Medicines Agency rejected Aduhelm.
According to data from the non-profit organization Alzheimer’s Europe, there are seven million people in Europe living with this debilitating disease and this number is expected to double by 2050.
