(Reuters) – Eli Lilly said on Tuesday a panel of independent U.S. FDA advisers will discuss whether the agency should approveits Alzheimer’s disease drug, donanemab, on June 10.
A possible approval for donanemab would pit it against a similar therapy by Eisai and partner Biogen, called Leqembi, which received the U.S. Food and Drug Administration’s approval last year.
Donanemab has faced two separate regulatory delays in the United States, one in January 2023, after the FDA declined accelerated approval, and another on March 8, when the agency said it would hold a meeting of its advisers to discuss the drug.
Donanemab, which is administered via once-a-month infusions, is designed to clear a toxic Alzheimer’s-linked protein called beta amyloid from the brain.
The FDA had conducted a meeting of this panel, called the Peripheral and Central Nervous System Drugs Advisory Committee, before approving Leqembi, which belongs to the same class of treatment.
(Reporting by Christy Santhosh in Bengaluru; Editing by Pooja Desai and Shinjini Ganguli)
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