Lilly Rolls Out Tirzepatide Obesity NDA with Priority Review Voucher, Aiming for Year-End FDA Approval

According to foreign media Endpoints, the team is "fervently" submitting the latest Phase III data of Mounjaro (Tirzepatide) for the treatment of obesity to the FDA, and will use a priority review voucher to shorten the review time from the standard 10 months to 6 months.

Mike Mason, Executive Vice President of the Company and President of Eli Lilly Diabetes, stated during the company's first-quarter earnings call that this could lead to the approval of the weight-loss indication by the end of this year. The rolling submission is already underway and is expected to be completed within the next few weeks.

On April 27, Eli Lilly announced the SURMOUNT-2 study data for Tirzepatide in treating obese or overweight adults with type 2 diabetes: a higher dose of Tirzepatide helped patients lose 15.7% of their body weight, or 15.6 kg, over 72 weeks, while a lower dose of Tirzepatide resulted in a 13.4% weight loss, or 13.5 kg.

Tirzepatide is a once-weekly GLP-1R/GIPR dual agonist that was first approved by the FDA for marketing in May 2022 for the treatment of type 2 diabetes. In September 2022, the indication's marketing application was accepted by the CDE. In October 2022, the FDA granted Tirzepatide Fast Track designation for adult obesity or overweight.

SURMOUNT-2 is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of once-weekly Tirzepatide (10mg, 15mg) in adult patients with obesity or overweight and type 2 diabetes.

The study enrolled a total of 938 subjects with an average baseline weight of 100.7 kg and a baseline A1C of 8.0%. Patients were randomized 1:1:1 to receive Tirzepatide 10 mg, 15 mg, or placebo. The co-primary endpoints were the percentage change in body weight and the proportion of patients achieving at least 5% weight loss in the Tirzepatide 10 mg and 15 mg groups at week 72.

Results showed that, compared with placebo, Tirzepatide (10mg and 15mg) achieved superior weight loss effects over placebo at 72 weeks of treatment. The study met both co-primary endpoints and all key secondary endpoints compared to placebo. Patients in the 10mg group experienced an average weight reduction of 13.4% (13.5kg), while those in the 15mg group had an average weight reduction of 15.7% (15.6kg), compared to 3.3% (3.2kg) in the placebo group. Additionally, 81.6% and 86.4% of patients in the 10mg and 15mg groups respectively lost more than 5% of their body weight, compared to 30.5% in the placebo group, achieving the co-primary endpoint.

Tirzepatide also met all key secondary endpoints, including reductions in A1C and other cardiometabolic parameters. The decrease in A1C was similar to that observed in the SURPASS trial in adults with type 2 diabetes compared to placebo.

Eli Lilly and Company has currently made a rolling submission to the FDA for the weight loss indication marketing application, with the expectation of completing the submission of all application documents by next year. This marketing application is primarily based on the data from the SURMOUNT-1 and SURMOUNT-2 studies. Additionally, data from the SURMOUNT-3 study targeting obese patients and the SURMOUNT-4 study aimed at maintaining weight loss in obese patients are expected to be released throughout 2023.

The SURMOUNT-1 study for non-type 2 diabetes patients with obesity was completed in May 2022. The results showed that Tirzepatide achieved two co-primary endpoints: compared with placebo, the percentage change in body weight from baseline was greater in the Tirzepatide group, and a higher proportion of patients in the Tirzepatide group achieved at least 5% weight loss.

The specific results are as follows: Compared with placebo (2.4%, 2kg), participants receiving 5mg Tirzepatide had an average weight loss of 16.0%, the 10mg group had an average reduction of 21.4%, and the 15mg group had an average decrease of 22.5% (equivalent to 24kg). Additionally, 89% (5mg) and 96% (10mg and 15mg) of patients in the Tirzepatide groups lost at least 5% of their body weight, compared to only 28% in the placebo group.

Notably, the China Phase III SURMOUNT-CN study of Tirzepatide, administered once weekly in non-type 2 diabetes patients who are obese or overweight with weight-related comorbidities, was completed in February 2023, achieving positive results by meeting the primary endpoint and all key secondary endpoints without presenting any new safety signals. Specific data is currently being compiled.

According to Eli Lilly's Q1 2023 financial report, Tirzepatide generated $568 million in sales this Q1. Evan David Seigerman, an analyst at BMO Capital Markets, recently predicted that considering indications such as type 2 diabetes and obesity, Tirzepatide's peak sales could reach $52 billion.

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