On Friday, the FDA announced it would postpone a decision on Eli Lilly's potential Alzheimer's treatment donanemab.
The U.S. Food and Drug Administration has postponed a decision on Eli Lilly’s potential Alzheimer’s treatment donanemab with an unusual request to have an advisory committee examine the drug. On Friday, the FDA announced it wanted to further understand topics related to evaluating the "safety and efficacy of donanemab," including the safety results of donanemab-treated patients. Lilly had expected the FDA to decide on donanemab's approval by the end of the month.
The 18-month study, published in the Journal of the American Medical Association , 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.
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In an unusual move, FDA postpones approval decision for Lilly’s Alzheimer’s drugBerkeley Lovelace Jr. is a health and medical reporter for NBC News. He covers the Food and Drug Administration, with a special focus on Covid vaccines, prescription drug pricing and health care. He previously covered the biotech and pharmaceutical industry with CNBC.
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