The FDA approved a similar infused drug, Leqembi, from Japanese drugmaker Eisai last year
PET scan of normal brain vs brain affected by Alzheimer’s disease
A closely watched Alzheimer’s drug from Eli Lilly won the backing of federal health advisers on Monday, setting the stage for the treatment’s expected approval for people with mild dementia caused by the disease.
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A panel of Food and Drug Administration advisers voted unanimously that the drug’s ability to modestly slow the disease outweighs its risks, including side effects like brain swelling and bleeding that will have to be monitored. “I thought the evidence was very strong in the trial showing the effectiveness of the drug,” said panel member Dean Follmann from the National Institutes of Health.
The FDA will make the final decision on approval later this year. If the agency agrees with the panel’s recommendation, the drug, donanemab, would only be the second Alzheimer’s drug cleared in the US to convincingly slow cognitive decline and memory problems due to Alzheimer’s. The FDA approved a similar infused drug, Leqembi, from Japanese drugmaker Eisai last year.
In a separate vote, the FDA advisers voted unanimously that the Lilly drug was shown effective in various subgroups of patients. Most FDA panellists thought there was enough evidence of the drug’s benefit to prescribe it broadly, without screening for the protein. Lilly studied its drug by grouping patients based on their levels of a brain protein, (tau) that predicts severity of cognitive problems.
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