Lilly Settles On Rolling Submission For Tirzepatide In Obesity

 
• By Joseph Haas
  
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Plan for rolling submission means US FDA filing of GIP/GLP1 agonist in obesity could be complete by April 2023, setting up possibility of late 2023 approval.

Accelerated process
Lilly hopes the rolling submission process will acclerate tirzepatide's path to the weight-loss market • Source: Shutterstock

Although Eli Lilly and Company had hoped to file its GIP/GLP-1 agonist tirzepatide to treat adults with obesity or who are overweight based just on data from the Phase III SURMOUNT-1 trial and earlier trials in type 2 diabetes, it is revising its regulatory strategy, presumably based on consultation with the US Food and Drug Administration. The pharma announced on 6 October that it got a fast track designation from the FDA and will make a rolling submission of its new drug application, which could be ready for review when SURMOUNT-2 data are expected in April.

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