On holding talks with the regulatory agency, the company intends to commence a rolling submission of a new drug application (NDA) for tirzepatide in adults for this indication this year.
This submission will be based on findings from two Phase III clinical trials, SURMOUNT-1 and SURMOUNT-2.
The SURMOUNT-1 trial assessed the safety and efficacy of 5mg, 10mg and 15mg tirzepatide versus placebo as an adjunct in adults with obesity or overweight with a minimum of one of the following comorbidities: dyslipidemia, hypertension, obstructive sleep apnea or cardiovascular disease.
SURMOUNT-2 is analysing the safety and efficacy of 10mg and 15mg tirzepatide versus placebo as an adjunct to a reduced-calorie diet and increased physical activity in obese or overweight adults with type 2 diabetes.
SURMOUNT-1 has concluded that SURMOUNT-2 is anticipated to be complete by the end of April next year.
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A once-weekly glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist, tirzepatide is a single new molecule.
In May, the FDA granted approval for tirzepatide as Mounjaro for use as an adjunct to diet and exercise to boost glycemic control in adults with type 2 diabetes mellitus.
Lilly Diabetes president Mike Mason said: “We are pleased with the FDA’s decision to grant Fast Track designation for tirzepatide, and we look forward to completing our rolling submission next year.
“We are dedicated to helping people living with obesity through our research and development of innovative treatments like tirzepatide, which produced significant weight reductions in patients taking tirzepatide for type 2 diabetes in SURPASS.
“Tirzepatide also helped nearly two-thirds of participants on the highest dose reduce their body weight by at least 20% in SURMOUNT-1.”