(Reuters) -Eli Lilly said on Tuesday a panel of independent U.S. FDA advisers will discuss its experimental Alzheimer's disease drug, donanemab, on June 10.
Donanemab has faced two separate regulatory delays in the United States, while a similar therapy by Eisai and partner Biogen, called Leqembi, received the U.S. Food and Drug Administration's approval last year.
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 approval.
Before approving Leqembi, which belongs to the same class of treatment as donanemab, the FDA had also conducted a meeting of an independent panel.
Lilly's donanemab, administered via once-a-month infusions, is designed to clear a toxic Alzheimer's-linked protein called beta amyloid from the brain.
In clinical trials, the treatment slowed the progression of memory and thinking problems by 22% to 29% overall, roughly comparable to the 27% slowing seen with Leqembi.
In patients with low-to-medium levels of a second Alzheimer's related protein called tau, Lilly's drug slowed the progression of the disease by 35.1% compared to a placebo.
Experts have, however, said the drug's association with side effects such as brain swelling and bleeding could pose a challenge to its approval. Three people who were on the treatment in the company's trial died.
Analysts on average expect donanemab to clock $65.6 million in sales in 2024, rising to $630.75 million next year, according to LSEG data.
(Reporting by Christy Santhosh in Bengaluru; Editing by Pooja Desai and Shinjini Ganguli)
