Eli Lilly
said results from a Phase 3 trial showed that the company’s investigational Alzheimer’s treatment donanemab significantly slowed cognitive and functional decline in people in the early stages of the disease.
Pharmaceutical company
Lilly
(ticker: LLY) said submission of donanemab to the Food and Drug Administration for traditional approval was completed last quarter with regulatory action expected by the end of the year. Submissions to other global regulators are underway, and the majority will be completed by the end of 2023.
“If approved, we believe donanemab can provide clinically meaningful benefits for people with this disease and the possibility of completing their course of treatment as early as six months once their amyloid plaque is cleared,” said Anne White, executive vice president of
Eli Lilly
and president of Lilly Neuroscience, in a press release.
Eli stock was falling 0.3% to $448.18 on Monday.
Earlier this month,
Biogen
(BIIB) received full approval from the FDA for its Alzheimer’s drug Leqembi. Safety issues concerning Alzheimer’s treatments still remain, however. In May, Lilly said three trial participants had died after developing brain swelling or bleeding issues from its Alzheimer’s treatment.
Write to Emily Dattilo at [email protected]
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