tupungato This article was updated at 355p ET with the results of the second vote. A panel of FDA advisors voted unanaimously that Eli Lilly's ( NYSE: LLY ) donanemab is effective in treating Alzheimer's disease in a population of patients with mild cognitive impairment and mild dementia. The vote was 11-0.
In briefing documents , FDA scientists suggested a safety warning for donanemab due to suspected brain hemorrhages, manifested as amyloid-related imaging abnormalities (ARIA). A second vote asking if the benefits of donanemab outweigh the risks was also unanimous in favor of the benefits. Several panel members said it was important that patients and caregivers be aware of the risks associated with the treatment.
An FDA action date has not been set for donanemab. If it is approved, it would compete with Biogen ( BIIB ) and Eisai's ( OTCPK:ESALF ) Leqembi (lecanemab). Donanemab has a dosing advantage over Leqembi in that the former is dosed every four weeks while the latter every two weeks.
However, Eisai's ( OTCPK:ESAIY ) supplemental Biologics License Application for every four week dosing of Leqembi was recently accepted by the FDA . Lilly shares closed ~2% higher on Monday. More on Eli Lilly Lilly's donanemab, remternetug set to dominate Alzheimer's treatment by 2030 Is It Possible Eli Lilly Is Breaking Out To New All-Time Highs? Eli Lilly's Growth And Challenges: A Cautious Buy Weight loss drugs other benefits could convince more men to use them - report Eli Lilly and C.
