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.
Lilly Settles On Rolling Submission For Tirzepatide In Obesity
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.
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