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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 ...
Lilly’s study enrolled people ages 60 to 85 who were in early stages of Alzheimer’s. Half received once-a-month infusions of donanemab and half dummy infusions for 18 months. The study had a ...
(Eli Lilly) The agency’s approval was based on a late-stage clinical trial of 1,700 people that showed the drug slowed the progression of Alzheimer’s by about 35% after 18 months, compared to ...
Lilly told a committee of FDA advisers in June that late-stage clinical research data showed “highly meaningful results” for people who took donanemab, with about 35% lower risk of progression ...
Donanemab is given to patients via an intravenous drip once every four weeks. Lilly has said that some patients can complete their course of treatment in as little as six months once their amyloid ...
(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 ...
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 ...
The Food and Drug Administration has pushed back its approval decision deadline for Eli Lilly’s experimental Alzheimer’s drug donanemab. Lilly applied to the FDA for approval of the drug in ...