FDA does not expedite approval of Alzheimer's treatment

This week, Eli Lilly and Company received disappointing news when the US Food and Drug Administration declined to grant accelerated approval to their experimental Alzheimer’s drug donanemab. The FDA requested additional data from the company before making a decision. The outcome of the Phase 2 clinical trial published in May in the New England Journal of Medicine showed that donanemab could lead to ‘modestly less cognitive and functional decline’ in patients with early Alzheimer’s, but the drug was also associated with some adverse events.

The Alzheimer’s Association released a statement in response to the FDA’s decision, expressing appreciation for the FDA’s rigorous approach in reviewing treatments and looking forward to the Phase 3 trial read-out expected later this year. Donanemab is intended to slow cognitive decline in Alzheimer’s patients, and is one of more than 300 Alzheimer’s treatments currently in clinical trials. Earlier this month, the FDA granted accelerated approval for the Alzheimer’s disease drug lecanemab, marketed as Leqembi.

Eli Lilly and Company will now have to submit additional data to the FDA for donanemab in order to reach a decision. The outcome of the Phase 3 trial read-out expected later this year and ongoing discussions between the company and the FDA will determine the drug’s future.


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