No date has been set for the advisory committee meeting.
The FDA often asks committees to review drugs that are first in their class of treatments. Donanemab, if approved, would follow Eisai’s Leqembi, which was approved last year, and Biogen’s Aduhelm.
The company said the agency wants to learn more from a pivotal study
The 18-month, late-stage study showed that patients taking donanemab declined about 22% more slowly in terms of memory and cognitive ability than those who received a dummy infusion. The delay amounted to about four to seven months.
In the study, patients were taken off the drug once their brain plaque reached low levels. Most patients reached that point within a year.
Donanemab is only the second drug that has been convincingly shown to delay the inevitable cognitive decline in patients with Alzheimer’s. The other is Leqembi.
Biogen announced earlier this year that it would stop selling Aduhelm.
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Donanemab, like Leqembi, comes with serious side effects that include brain swelling and bleeding. Those are common to all plaque-targeting drugs and require close monitoring.
About a quarter of donanemab recipients showed evidence of that swelling, and about 20% had microbleeds.
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Perrone reported from
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