FDA will review Eisai and Biogen's Alzheimer's treatment Leqembi with decision on full approval expected in early July
Publishing timestamp: 2023-03-06 10:45:23
Summary
The FDA will make a decision on full approval of Eisai and Biogen's Alzheimer's treatment Leqembi by July 6. Medicare has agreed to provide broader coverage on the same day Leqembi receives full FDA approval, but only for people who participate in research studies. The Alzheimer's Association has called on CMS to provide unrestricted coverage of treatments like Leqembi, but CMS rejected the request. Eisai's U.S. CEO believes Medicare could agree to provide coverage with no restrictions after Leqembi receives full approval.
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