The EMA’s Committee for Medicinal Products for Human Use expressed concern about brain complications associated with the Eisai Alzheimer’s drug, Leqembi. Eisai said it will ask the committee to reconsider the negative opinion.
Six months after Esai Alzheimer’s disease drug Leqembi received accelerated FDA approval, the agency has awarded the drug full approval. While the agency’s regulatory decision sets precedent for other Alzheimer’s drugs, it also flags serious safety risks.
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Medicare will cover Alzheimer’s disease drugs granted traditional FDA approval, CMS announced. But the decision keeps the spirit of an earlier coverage determination, which called for the gathering of more evidence about the safety and efficacy of these therapies.
Leqembi, the Eisai Alzheimer’s disease drug awarded accelerated FDA approval in January, could receive a decision on full approval in early July. But in setting the target date for a regulatory decision, the agency also said it plans to convene an advisory committee meeting to discuss the drug.
Eisai Alzheimer’s disease drug Leqembi is now approved for the treatment of patients with an early form of the memory-robbing disease. In granting the antibody accelerated approval, the FDA employed reasoning that was the also basis for the controversial speedy regulatory nod for Biogen’s drug, Aduhelm.