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FDA Should Not Approve Flawed Alzheimer’s Disease Drug Donanemab

WASHINGTON, D.C. – A Food and Drug Administration (FDA) advisory committee on Monday discussed an application for approval of donanemab for the treatment of Alzheimer’s disease. The subjects in the clinical trials had mild cognitive impairment and mild dementia.

In testimony, Public Citizen’s Health Research Group urged the committee to recommend that the FDA not approve donanemab. Nonetheless, for the population enrolled in the clinical trials, the committee voted 11-0 that donanemab is effective for the treatment of Alzheimer’s disease, and 11-0 that the benefits of donanemab outweigh the risks. Dr. Robert Steinbrook, director of Public Citizen’s Health Research Group, released the following statement:

“The advisory committee meeting was very disappointing. The essential issue was not the specifics of the potential prescribing information for donanemab but whether the drug should be approved to begin with. The FDA should never have approved the Alzheimer’s disease drugs aducanumab (Aduhelm) and lecanemab (Leqembi). It should not make the same mistake a third time by approving donanemab.

“All three drugs have the same problem: their purported benefits in slowing the progression of Alzheimer’s disease do not outweigh their substantial health risks, including brain swelling and bleeding. Fortunately, aducanumab was little used and is being withdrawn from the U.S. market.

“Although patients with Alzheimer’s disease and their families are desperate for effective treatments, donanemab is not the answer, and should not be approved.”