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FDA advisers say Eli Lilly Alzheimer's treatment is effective
  + stars: | 2024-06-10 | by ( ) www.cnbc.com   time to read: 1 min
In this videoShare Share Article via Facebook Share Article via Twitter Share Article via LinkedIn Share Article via EmailFDA advisers say Eli Lilly Alzheimer's treatment is effectiveDr. Scott Gottlieb, Former FDA Commissioner, joins 'Closing Bell Overtime' to talk news that the FDA has deemed Eli Lilly's Alzheimers treatment as effective.
Persons: Eli Lilly Alzheimer's, Scott Gottlieb, Eli Lilly's Organizations: FDA
FDA Commissioner Dr. Robert Califf speaks at an event celebrating hearing aids being available over the counter at a Walgreens in Washington, D.C., Oct. 19, 2022. Food and Drug Commissioner Dr. Robert Califf praised results Eli Lilly announced Wednesday that a clinical trial showed its Alzheimer's treatment donanemab slowed progression of the disease. "We have to look at the data when it comes in before making a judgment, but if the data look as good as the press release — this is really, really exciting," the commissioner said. The antibody treatment also carries risks of brain swelling and bleeding that can be severe and even fatal in rare circumstances. Full-time civil servants who are prohibited from having financial conflicts of interest make those decisions, the commissioner said.
Eli Lilly on Wednesday said it will halt development of its Alzheimer's treatment candidate solanezumab after the antibody failed to slow disease progression. The study enrolled more than 1,000 seniors who had normal memory and thinking function, but showed signs of brain plaque that is associated with Alzheimer's. Lilly said it did not have that data because donanemab cleared brain plaque quickly in many patients. "We remain confident in the of potential donanemab as a new treatment for people with early symptomatic Alzheimer's disease," Skovronsky said. The FDA approved Eisai's and Biogen's early Alzheimer's treatment Leqembi on an expedited basis in January.
Jan 20 (Reuters) - The U.S. health regulator's rejection of accelerated approval for Eli Lilly and Co's Alzheimer's disease drug extends the market lead for rivals Eisai and Biogen's treatment by months, analysts said. "This is a modest positive for Biogen" because it delays donanemab's launch, Jefferies analyst Michael Yee said, adding that Eli Lilly could file for traditional approval by mid-2023. The setback for Lilly comes just weeks after the FDA granted Biogen Inc (BIIB.O) and Japanese drugmaker Eisai Co Ltd's (4523.T) accelerated approval for their Alzheimer's drug Leqembi. read moreAnalysts are waiting for the traditional approval of Biogen's drug and for wider health insurance coverage before they expect sales of the drug to pick up. "But if there is anything wrong with the (Eli Lilly) data set, it is easier to reject an unapproved drug than remove an approved drug from market," said Skorney.
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