The FDA is poised to grant full approval for Biogen and Eisai's Leqembi drug, which has been developed as a treatment for Alzheimer's disease. The decision is based on data from the pivotal trial Study 301, which showed consistently favorable results for primary and secondary endpoints. In July 2023, the FDA may grant full approval following a vote by an advisory committee that has been asked to verify whether the study confirms lecanemab’s clinical benefit. Safety signals such as cerebral hemorrhage and infusion-related reactions are not deemed to preclude traditional approval of lecanemab. Following previous uncertainty around coverage costs, Medicare announced last week that it will pay for new Alzheimer’s drugs after they receive full FDA approval. However, physicians must be required to record patient symptoms in a government registry.
Keywords: FDA, Eisai, Biogen, Leqembi (lecanemab), Alzheimer’s disease
Additional sentence: After receiving conditional approval earlier this year from the FDA as only the second drug approved in two years for treating Alzheimer's disease patients have seen benefits with Lecanamab; however there was doubt over whether Medicare would cover it upon full approval but now CMS administrator Chiquita Brooks-LaSure said Thursday that Medicare will pay for new