(Reuters) – The U.S. Food and Drug Administration (FDA) has postponed by several months the announcement of its opinion on donanemab, an experimental treatment for patients with early-stage Alzheimer’s disease, the company said .
The action of the American drug manufacturer fell by almost 1%, to 773 dollars (707 euros), in pre-market trading on Friday.
No date has yet been set for the meeting of the advisory committee responsible for examining the treatment, said the laboratory, which however did not announce any change in its financial forecasts for 2024.
“It was really unexpected for us,” Anne White, president of Lilly Neuroscience, commented in an interview.
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This news, she noted, came very late in the review process and just as the company was ready to launch treatment.
Lilly expected a decision to be made late last year, but in November the FDA pushed that date back to the first quarter of 2024 because it needed more time to review the application. authorisation.
Anne White said the FDA wanted the panel to discuss specific aspects of the clinical trial, including issues related to effectiveness and safety. The treatment is associated with swelling and brain hemorrhages, and three people treated in the company’s trial have died.
Donanemab would compete with a rival treatment, Leqembi, from Eisai and Biogen, which the FDA granted standard approval last year and which works similarly.
Analysts on average forecast donanemab sales of $189.6 million in 2024, rising to $837 million next year, according to LSEG data.
(Reporting Julie Steenhuysen in Chicago and Patrick Wingrove in New York, with contributions from Bhanvi Satija in Bangalore, French version Alban Kacher, editing by Kate Entringer)
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