If approved, Eli Lilly's donanemab would become the second Alzheimer's drug of its kind to enter the market after Leqembi from Biogen and Eisai.
A panel of independent advisors to the FDA recommended Eli Lilly's Alzheimer's drug donanemab, paving the way for the treatment to receive full approval in the U.S. later this year.
In a first vote, 11 committee members unanimously said available data on the drug shows that it is effective at treating Alzheimer's patients at the early stages of the mind-wasting disease. But several advisors noted that more data is needed on donanemab in Black and Hispanic patients, among other groups.
It was another blow to Eli Lilly, which initially expected donanameb to win approval at the end of last year. The FDA alsoLeqembi and donanemab are milestones in the treatment of Alzheimer's after three decades of failed efforts to develop medicines that can fight the fatal disease. In a note Sunday, Leerink Partners analyst David Risinger said he expects limited commercial adoption of donanemab relative to Leqembi because Eli Lilly's drug has "more safety liabilities" and will be less convenient, since it is administered once a month through the veins. That is a method known as intravenous infusion.
Most advisors agreed that tau tests should not be required to access donanemab because it would likely restrict the population who can benefit from the drug.
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