1. Scrip
  2. >>New Products

Three Strikes, But Not Out Yet, Lilly’s Donanemab Approval Delayed Again

Accelerated Approval Snub Was More Than A Year Ago

 
• By Mandy Jackson

The US FDA wants to hold an advisory committee meeting for Lilly’s donanemab in early Alzheimer’s disease, which means approval will now occur after the expected Q1 decision date.

Brain Xray
Donanemab safety and efficacy both are likely topics for the Adcomm • Source: Shutterstock

US Food and Drug Administration approval for Eli Lilly and Company’s donanemab has been delayed for a third time now that the agency has decided to convene a meeting of its Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to discuss the Phase III TRAILBLAZER-ALZ 2 trial results for the anti-amyloid antibody in early Alzheimer’s disease. Lilly expected approval during the first quarter of 2024 but said on 8 March that this is no longer likely.

Key Takeaways

  • After the US FDA declined to grant accelerated approval for Lilly’s donanemab and pushed out the action date for potential full approval last year, the agency again delayed its decision because it wants to convene an advisory committee meeting.

This is the third time that donanemab’s approval has been pushed back, starting with the FDA’s decision to issue a...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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 New Products

Pipeline Watch: Eight Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

UroGen Gets A First-Ever Bladder Cancer Approval Despite US FDA AdComm ‘No’ Vote

 
• By Joseph Haas

UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.

Nuvation Set For First Launch With Ibtrozi In Lung Cancer

 
• By Jessica Merrill

The US FDA approved taletrectinib for the treatment of ROS1+ NSCLC, where Nuvation hopes it will lead the category with a best-in-class position.

Pipeline Watch: ASCO Dominates Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

More from Scrip

Profit-Sharing AI Model Proposed To Boost Korean Drug R&D

 
• By Jung Won Shin

A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges

Sarepta Market Dynamics For Elevidys Imperiled By Second Patient Death

 
• By Joseph Haas

With two deaths in non-ambulatory DMD patients, Sarepta is attempting damage control and will ask the US FDA to advise, setting up a possible confrontation with CBER director Prasad.

Supernus Secures Sage With CVR-Supported Deal

 
• By Jessica Merrill

Supernus agreed to pay $561m upfront plus a contingent value right that could add $234m to buy Sage, topping a previously rejected offer from Biogen.