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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...

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More from Approvals

EU Pharma Reform: Lawyers Unpack Diverging Visions For Innovation

 
• By Eliza Slawther

There are now three draft versions of the legislative text that will overhaul the framework governing pharmaceuticals in the EU. Lawyers explain how the approaches proposed by the European Commission, European Parliament and Council of the EU differ and highlight implications for industry.

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.

More from Product Reviews

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.

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

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.