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Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT 24.06

US FDA Advisory Committee recommends approval of Eli Lilly donanemab

On June 10, 2024, the US FDA Peripheral and Central Nervous System Drugs Advisory Committee panel recommended approval of Eli Lilly’s donanemab for the treatment of early-stage Alzheimer’s disease.

The panel voted 11-0 that donanemab’s benefit outweighs its risks. It also voted 11-0 that the data presented by Eli Lilly showed that the drug was effective in the early stage of the disease.

Donanemab showed a 37% lower risk of progression of a clinical measure of dementia in patients treated over 76 weeks.

One of the members of the panel said if donanemab is approved, patients should carry a medical information card to indicate that they are being treated with the drug in order to inform doctors and caregivers of the risk if they also receive a blood thinner.

The panel also discussed in some length the fact that donanemab was more effective in patients with low tau levels and less advanced disease and was wondering if the drug should be restricted to patients with low-to-medium tau levels in their cerebrospinal fluid and how to extrapolate to patients with no tau levels, a group which had been excluded from the study.

The FDA usually follows the recommendation of its advisory panel. The final decision on donanemab approval by the FDA has already been delayed twice and is now expected by the end of the year. It is not known if a similar dossier has been filed by Eli Lilly in Europe or in Japan.

Paris, June 11, 2024.

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