In review of Lilly Alzheimer’s drug, FDA staff focus on safety, patient selection

BioPharma Dive June 6, 2024
Jonathan Gardner

Documents prepared by agency scientists ahead of a Monday advisory committee meeting highlight questions on the drug’s risks as well as on the unusual design of Lilly’s clinical trial.

Dive Brief:

• Expert advisers to the Food and Drug Administration will need to weigh whether Eli Lilly’s experimental Alzheimer’s disease drug donanemab is widely effective or should be restricted only to people who have deposits in their brains of a toxic protein called tau, according to documents released Thursday ahead of a key regulatory meeting next week.
• The FDA will also ask its advisers to provide guidance on whether and when it’s safe for people to stop taking donanemab based on reductions in another toxic protein called amyloid, as well...

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