Pricey Alzheimer’s Drug Coverage Hinges on FDA Decision

June 15, 2023, 9:25 AM UTC

Expanded access to the Alzheimer’s drug that Eisai Co. developed with Biogen Inc. is unlikely to happen quickly even if the FDA decides follow-up studies confirm the drug helps slow the disease, health policy analysts and researchers say.

Patient advocacy groups are anxiously awaiting what they hope will be a favorable decision by the Food and Drug Administration on Leqembi’s traditional approval application, which six independent advisers to the agency voted unanimously in support of last week.

The FDA’s final decision is expected by early July on the pricey drug, which was previously cleared under the agency’s accelerated approval pathway ...

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