Tuesday, the FDA mentioned it will convene an in-person assembly of the Peripheral and Central Nervous System Medication Advisory Committee on Monday, June 10, 2024, to debate Eli Lilly and Co’s LLY donanemab for early symptomatic Alzheimer’s illness.
The open public listening to portion of the assembly shall be carried out just about.
The Section 3 research submitted as a part of this software, TRAILBLAZER-ALZ 2, is a double-blind, placebo-controlled research to judge the protection and efficacy of donanemab in members ages 60-85 years with early symptomatic Alzheimer’s illness.
In March, the company mentioned that it desires to know subjects associated to evaluating the protection and efficacy of donanemab, together with the protection ends in donanemab-treated sufferers and the efficacy implications of the distinctive trial design of the TRAILBLAZER-ALZ 2 research, together with its limited-duration dosing routine that allowed sufferers to finish therapy based mostly on an evaluation of amyloid plaque and the inclusion of members based mostly on tau ranges.
Final yr in March, Eli Lilly launched the outcomes of the TRAILBLAZER-ALZ 2 Section 3 research of donanemab for Alzheimer’s illness.
Donanemab therapy slowed medical decline by 35% in comparison with placebo and resulted in 40% much less decline on the flexibility to carry out actions of every day residing.
Lilly continues to review donanemab in a number of medical trials, together with TRAILBLAZER-ALZ-3, learning donanemab for the prevention of Alzheimer’s illness.
Value Motion: LLY shares are up 0.88% at $773.40 eventually test Tuesday.
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