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

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

More from Approvals

Blenrep’s Comeback Continues As England Becomes First To Fund Drug

 

Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.

Argentina Speeds Up Market Access Process

 

Companies operating in Argentina may get their medicines to the market more quickly thanks to new updates to the medicines authorization system.

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Vyjuvek, Krystal Biotech's advanced therapy for treating dystrophic epidermolysis bullosa.

More from Product Reviews

US FDA’s Rising First-Cycle Complete Response Rate Draws Congress’ Attention

 
• By 

The House Appropriations Committee wants an analysis of how issues that led to CRLs could have been resolved within the first review cycle and seeks an agency crackdown on counterfeit GLP-1 agonists.

‘Clean Sweep’ Of US CDC Vaccine Committee Puts Kennedy In Driver’s Seat

 

With a 25-27 June meeting looming, HHS Secretary Robert F. Kennedy Jr. can fill all 17 spots on the CDC's Advisory Committee on Immunization Practices with people he says will "exercise independent judgment."

Infographic: Leqembi – A Geographical Comparison

 

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.