(CercleFinance.com) – Eli Lilly reports that the US Food and Drug Administration (FDA) plans to convene a meeting of the Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee to discuss a trial phase 3 study evaluating the efficacy and safety of donanemab in early symptomatic Alzheimer’s disease.
The FDA has informed Lilly that it is interested in better understanding topics related to the evaluation of the safety and effectiveness of donanemab.
The advisory committee meeting date for donanemab has not yet been set by the FDA and, therefore, the timeline for expected FDA action on donanemab will be delayed beyond the first quarter of 2024.
‘We are confident in the potential of donanemab to provide very significant benefits to people with early symptoms of Alzheimer’s disease. “It was unexpected to learn that the FDA would be convening an advisory committee at this stage of the review process, but we will work with the FDA to answer all questions,” said Anne White, executive vice president of FDA. Eli Lilly and Company and President of Lilly Neuroscience.
Copyright © 2024 CercleFinance.com. All rights reserved.
Did you like this article ? Share it with your friends using the buttons below.
