Eli Lilly and Company received Fast Track designation from the US Food and Drug Administration (FDA) for tirzepatide to treat adults with obesity or weight-related comorbidities. The US FDA grants Fast Track designation to facilitate development and expedite the review of medicines used for the treatment of serious conditions or diseases and to fulfil unmet medical needs.
Based on discussions with the US FDA, Eli Lilly is planning to initiate a submission of a new drug application (NDA) for tirzepatide in adults suffering from obesity this year, which will be primarily based on the results from two phase 3 clinical trials. The rolling submission will allow Eli Lilly to submit complete sections of an application for review by the US FDA, rather than wait until all the sections are completed.
Mike Mason, president of Lilly Diabetes, said that they are very happy with the decision of the US FDA to grant Fast Track designation for tirzepatide, and they look forward to completing their rolling submission in 2023.
Mike Mason added that obesity is a chronic disease that impacts the health of 100 million people in the United States, and is a significant driver of healthcare costs in the country.