FDA converts novel Alzheimer’s disease treatment to traditional approval

FDA

6 July 2023 - Action follows confirmatory trial to verify clinical benefit.

Today, the US FDA converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer’s Disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit.

Read FDA press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US