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Ahead of key meeting, FDA appears open to full approval of Alzheimer’s drug Leqembi

June 7, 2023


A closely watched Alzheimer’s disease medicine appears to be heading toward broader approval, as documents released Wednesday show the Food and Drug Administration appears to have few concerns with it.

The medicine, known scientifically as lecanemab and commercially as Leqembi, was granted a conditional approval earlier this year, based on results from a roughly 850-person study that convinced FDA staff it was reasonably likely to provide some level of benefit to Alzheimer’s patients.

Leqembi’s developers, Eisai and Biogen, have since been trying to secure a full approval. If they succeed, insurance companies are expected to offer much broader coverage of Leqembi and other, similar drugs, which would make them more accessible to patients as well as far more lucrative to their manufacturers.

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