Published 1 year ago

FDA declines to grant accelerated approval for Eli Lilly's experimental Alzheimer's treatment

Summary by Ground News

The FDA declines to grant accelerated approval to an experimental Alzheimer's drug. The drug maker, Eli Lilly, plans to file Phase 3 clinical trial data later this year. Alzheimer's Association says it "appreciates" the FDA's process for reviewing treatments. The experimental intravenous drug donanemab is not a cure, but intended to slow cognitive decline.

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USA Today

Why the FDA rejected Eli Lilly's attempt for quick approval of Alzheimer's drug

Shares of Eli Lilly and Co. dropped Friday after news that the FDA rejected the company's accelerated approval for its Alzheimer's drug donanemab.

1 year ago·United States

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CNN

FDA declines to grant accelerated approval for Eli Lilly's experimental Alzheimer's treatment

The US Food and Drug Administration declined to grant accelerated approval to an experimental Alzheimer's drug, donanemab, and requested additional data from Eli Lilly and Company, the drug maker.

1 year ago·Atlanta, United States

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The Washington Post

FDA declines to give accelerated approval to Eli Lilly’s Alzheimer’s drug, firm says

The Food and Drug Administration said it needed safety data on more patients, the company said.

1 year ago

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Medscape

FDA Says No to Accelerated Approval for Alzheimer's Drug

The FDA has denied accelerated approval of donanemab for early Alzheimer's disease, but will evaluate traditional approval when more data are released from the phase 3 TRAILBLAZER ALZ trial.

1 year ago·United States

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WISH-TV

FDA declines to grant accelerated approval for Lilly's experimental Alzheimer's treatment

(CNN) — The US Food and Drug Administration declined to grant accelerated approval to an experimental Alzheimer’s drug, donanemab, and requested additional data from Eli Lilly and Company, the drug maker. The company, which announced the development on Thursday, plans to file Phase 3 clinical trial data later this year for a traditional FDA approval. The findings in a previous Phase 2 trial, published in May in the New England Journal of Medicin…

1 year ago·Indianapolis, United States

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KWWL

FDA declines to grant accelerated approval for Eli Lilly's experimental Alzheimer's treatment

The US Food and Drug Administration declined to grant accelerated approval to an experimental Alzheimer's drug, donanemab, and requested additional data from Eli Lilly and Company, the drug maker.

1 year ago·Waterloo, United States

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FDA declines to grant accelerated approval for Eli Lilly's experimental Alzheimer's treatment

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Why the FDA rejected Eli Lilly's attempt for quick approval of Alzheimer's drug

Why the FDA rejected Eli Lilly's attempt for quick approval of Alzheimer's drug

FDA declines to grant accelerated approval for Eli Lilly's experimental Alzheimer's treatment

FDA declines to grant accelerated approval for Eli Lilly's experimental Alzheimer's treatment

FDA declines to give accelerated approval to Eli Lilly’s Alzheimer’s drug, firm says

FDA declines to give accelerated approval to Eli Lilly’s Alzheimer’s drug, firm says

FDA Says No to Accelerated Approval for Alzheimer's Drug

FDA Says No to Accelerated Approval for Alzheimer's Drug

FDA declines to grant accelerated approval for Lilly's experimental Alzheimer's treatment

FDA declines to grant accelerated approval for Lilly's experimental Alzheimer's treatment

FDA declines to grant accelerated approval for Eli Lilly's experimental Alzheimer's treatment

FDA declines to grant accelerated approval for Eli Lilly's experimental Alzheimer's treatment

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