1. Pink Sheet
  2. >>Product Reviews

US FDA Rejects Lilly’s Bid For Donanemab Accelerated Approval In Early Alzheimer’s

Eisai/Biogen’s Leqembi Remains Lone Anti-Amyloid In US

 
• By Mandy Jackson

More long-term data for donanemab needed, FDA says. Lilly plans to seek traditional approval for its amyloid-clearing antibody after the Phase III TRAILBLAZER-ALZ 2 trial reads out in Q2, but it loses important ground in reimbursement negotiations.

PET CT scan of Human Brain (Axial view Positron Emission Tomography)
The FDA wants longer-term data from more patients • Source: Shutterstock

Eli Lilly and Company has failed to win accelerated approval for its Alzheimer’s candidate donanemab after the US Food and Drug Administration determined more long-term data was needed. 

The complete response letter cited “the limited number of patients with at least 12 months of drug exposure data” in the company’s application, Lilly said late on 19 January

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Complete Response Letters

More from Product Reviews