1. Pink Sheet
  2. >>Product Reviews
  3. >>Approvals

Lilly’s Kisunla: Labeling Allows For Stopping Treatment Based On Amyloid Plaque Reduction

 
• By Sue Sutter

However, the US FDA’s approval of donanemab comes with little guidance on when to stop treatment or when the anti-amyloid agent may need to be restarted in Alzheimer’s patients.

Stop light
Patients may stop taking Kisunla when amyloid plaque is reduced to 'minimal levels' on PET imaging. • Source: Shutterstock

US labeling for Eli Lilly and Company’s Alzheimer’s drug Kisunla (donanemab-azbt) allows for treatment cessation upon clearance of amyloid plaque, but offers little guidance on how to do that or when the drug may need to be restarted.

Key Takeaways

  • The FDA approved Lilly’s donanemab with labeling that states providers may consider stopping dosing based on a reduction of amyloid plaques to minimal levels in PET imaging.

“Consider stopping dosing with Kisunla based on reduction of amyloid plaques to minimal levels on amyloid PET imaging,” labeling...

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 Approvals

New EU Filings

 
• By Neena Brizmohun

Linerixibat, GSK's treatment for cholestatic pruritus in patients with primary biliary cholangitis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

EMA Nod For First MASH Drug Rezdiffra, Cell Therapy Zemcelpro And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.

Lerodalcibep And First Generic Palbociclib Among 10 New EMA Filings

 
• By Neena Brizmohun

Lerodalcibep and palbociclib are among the latest new drugs that the European Medicines Agency has started to review for potential EU marketing authorization.

EU Decision Time For Madrigal’s MASH Drug Resmetirom And 11 Others

 
• By Eliza Slawther

Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.

More from Product Reviews

National Priority Voucher Gives US FDA Commissioner Tool For Radical Regulatory Surgery

 
• By Bridget Silverman

US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.

Kisunla Back In The Spotlight As EMA Reconsiders Alzheimer’s Drug Rejection

 
• By Eliza Slawther

It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.

Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.