Advisors to the Food and Drug Administration have recommended unanimously that the agency approve the Alzheimer’s drug donanemab.
An advisory committee to the Food and Drug Administration has recommended that the federal agency approve Alzheimer's drug donanemab.
If the FDA follows the committee’s recommendation, donanemab would join a similar drug, sold under the brand name Leqembi, which wasDuring a day-long discussion, committee members noted that, if approved, donanemab would have some apparent advantages over Leqembi. The older drug is given every two weeks indefinitely, while the newer one is given monthly and could be stopped for some patients.
After being initially rebuffed by the FDA, Eli Lilly applied for traditional approval in mid-2023, which usually would have resulted in a decision by the end of the year. “It is critical to do whatever we can to have an impact to slow this terrible, inexorably progressive disease,” said Dr. Reisa Sperling, who directs the Center for Alzheimer Research and Treatment at Brigham and Women’s Hospital in Boston and has served as a consultant to several drug companies.
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