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(Reuters) -Outside advisers to the U.S. Food and Drug Administration on Monday voted unanimously that the benefits of Eli Lilly's experimental Alzheimer's treatment donanemab outweighed its risks ...
The approval for donanemab, to be sold under the brand name Kisunla, followed the recommendations of the agency's outside experts, who unanimously backed its use in patients with early Alzheimer's ...
In Lilly’s studies, the death rate from ARIA was about 2.3% in those receiving donanemab compared to 1.9% in the placebo group after three years. What the committee found
Lilly Biotechnology Center in San Diego, Calif. Credit - Getty Images. O n July 2, the U.S. Food and Drug Administration (FDA) approved a new drug for treating Alzheimer’s disease. Donanemab, or ...
Lilly had expected the Food and Drug Administration to decide on donanemab's approval by the end of the month. The FDA often asks committees to review drugs that are first in their class of ...
The Food and Drug Administration approved a new Alzheimer’s drug from Eli Lilly that has been shown in clinical trials to modestly slow a decline in memory and thinking abilities in people with ...
Last year, the FDA approved one of the first drugs to slow Alzheimer's, a drug similar to donanemab called lecanemab or Leqembi, made by Eisai and Biogen, Tokyo and Massachusetts-based companies.
Lilly's donanemab was declined accelerated approval by the FDA in January 2023, and on March 8, the agency said it would hold a meeting of its advisers to discuss the drug, further delaying its ...