FDA’s Full Approval of Alzheimer’s Drug Leqembi Expected in July

A mid-2023 full approval decision from the Food and Drug Administration is expected for Eisai and Biogen’s Alzheimer’s drug, Leqembi, according to a joint statement from the companies. The antibody treatment, which is administered intravenously twice monthly, is fresh off the heels of proving it can slow progression of early Alzheimer’s disease by 27% in clinical trials. It does so by targeting the harmful brain plaque associated with the disease. But despite the anticipated full approval from the FDA, some downsides include the possibility of triggering brain swelling and the sizable annual price tag of $26,500, which may hamper commercialization efforts.

The initial expedited FDA green light in January led to The Centers for Medicare and Medicaid Services teasing an offer of broader coverage if the drug were to gain full approval. Currently, access to Leqembi is essentially a no-go. Medicare will only cover classes of drugs like Leqembi that are approved on an expedited basis for clinical trial participants to aggregate real-world data.

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In late 2022, the Alzheimer’s Association invoked CMS to grant unrestricted coverage of much needed treatments such as Leqembi, and several Congressmembers have also called on the agency to broaden its coverage. A common argument from U.S. politicians is that existing restrictions put those in rural communities at a disadvantage, given that the providers that participate in associated studies tend to be located in larger cities.