The FDA has released briefing documents for Eli Lilly's experimental Alzheimer's drug, donanemab. These documents include two voting questions with specific instructions from the agency. FDA staff are considering a more targeted approval for the treatment than Eli Lilly desires. A panel of outside experts will meet on Monday to vote on the safety and efficacy data for donanemab and make recommendations to the FDA. This drug is seen as a potential rival to Eisai and Biogen's Leqembi. FDA reviewers have raised questions about whether approval should be restricted to a smaller group of patients. Despite this, FDA staff have raised no major concerns about the drug. Eli Lilly shares were down 0.1% pre-market following the release of the documents.
US FDA staff raise no major concerns about Eli Lilly Alzheimer's drug https://t.co/RmMl1xywQC https://t.co/k6TZavsYpi
FDA reviewers ask if approval of Lilly’s $LLY Alzheimer’s drug should be restricted to a smaller group https://t.co/IOQ7jYWALr via @matthewherper @elaineywchen
FDA reviewers ask if approval of Lilly’s Alzheimer’s drug should be restricted to a smaller group $LLY https://t.co/DJI3z0Hbmv
The Cliff Notes version of the FDA donanemab briefing docs available now at @FierceBiotech: https://t.co/aK1506J8Jb
Scientists at the FDA have two big questions about Eli Lilly’s experimental Alzheimer’s drug donanemab. https://t.co/pBEnpyuKbS
FDA Staff Proposes Narrow Approval for Lilly Alzheimer Drug https://t.co/S6fuSYXiqZ $lly $biib
$LLY not that it matters to them - the Donanemab Adcom coming - I'd be surprised they get a -ve panel vote on both questions - however, I think the discuz on whether patients can stop treatment based on PET imaging will be more uncertain - Clearly FDA did not want them to use… https://t.co/1uJlqhqDf4
A panel of outside experts to the U.S. health regulator will meet on Monday to vote on safety and efficacy data for Lilly's LLY.N donanemab, a potential rival to Eisai and Biogen's Leqembi, and make recommendations to the FDA. https://t.co/n0ijoUSiQm https://t.co/n0ijoUSiQm
US drug regulatory staffers are considering a more targeted approval for Eli Lilly’s experimental Alzheimer’s disease treatment than the company wants. https://t.co/OZ31DzGhO1
$LLY (-0.1% pre) Eli Lilly & Co. (LLY) on Watch After FDA Posts Documents Ahead of Panel Meeting for AD Drug https://t.co/WLm35Kpiuj
FDA briefing documents for $LLY's Alzheimer's drug are posted: https://t.co/LOd2BJ9kdV Two voting questions, with some very specific instructions from the agency: https://t.co/A4iTZpxFJw
FDA briefing documents for $LLY donanemab advisory panel are posted https://t.co/MlrBRUIb8Z
FDA briefing docs on donanemab for Alzheimer’s are up. https://t.co/xgKqBe4wx4