Lilly To Seek Full Approval Of Alzheimer’s Drug After FDA Nixes Accelerated Approval

By Gabrielle Wanneh / January 20, 2023 at 6:47 PM
Eli Lilly plans to collect additional data and seek full approval of its Alzheimer’s drug candidate later this year -- a move that could potentially get it out from under the class-wide coverage limits CMS instilled when Biogen’s first Alzheimer’s drug received accelerated approval -- after FDA shot down Lilly’s request for accelerated approval Thursday (Jan. 19). Eli Lilly announced that FDA decided not to grant accelerated approval of the company’s Alzheimer’s drug candidate donanemab because not enough patients used...

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