Lilly also outlined its plans to initiate a rolling submission of a new drug application (NDA) for tirzepatide in adults with obesity or overweight this year, which when complete, will be based predominantly on results from two phase 3 clinical trials: SURMOUNT-1, which is complete, and SURMOUNT-2, which is expected to complete by the end of April 2023.
Under the rolling review, Lilly will be able to submit parts of its application to the FDA as they finish out rather than waiting until all sections are completed, with the company adding that it hopes to complete the submission shortly after SURMOUNT-2 data is available.
