FDA AdComm Will Tussle With Donanemab’s High ARIA Rate in June 10 Meeting

Eli Lilly will make a case for its antiamyloid antibody donanemab on June 10, trying to reassure the Peripheral and Central Nervous System Advisory Committee that the drug is safe, despite the serious adverse events related to the deaths of five people during the drug’s pivotal phase 3 trial.

But safety is just one of several concerns the FDA raised in its pre-meeting briefing documents. The agency also wants committee members to weigh in on Lilly’s proposed unique dosing scheme, which would allow patients with Alzheimer’s disease to stop taking the drug after it clears the bulk of their brain amyloid. That’s not been an option with either Biogen’s Aduhelm (aducanumab) nor Eisai’s Leqembi (lecanemab), which — theoretically at least — would be given for the rest of a patient’s life.

The briefing documents also contained some additional mortality data on the patients who died from complications of ARIA. Three died during the placebo-controlled period and two more people died after all of the placebo patients had crossed over to the active treatment.

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