Eli Lilly’s Mounjaro (Tirzepatide) Granted FDA Fast Track Designation for Obesity Treatment

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News / BIOON / -- Eli Lilly recently announced that the U.S. Food and Drug Administration (FDA) has granted Mounjaro (tirzepatide) Fast Track Designation (FTD):For the treatment of obese or overweight adult patients with weight-related comorbidities.

Mounjaro is a novel, once-weekly GIP and GLP-1 receptor agonist., which received U.S. FDA approval in May 2022:Adjunct to diet and exercise for the improvement of type 2DiabetesBlood Glucose Control in Adult Patients with T2D. It is worth mentioning that,Mounjaro is the first GIP/GLP-1 receptor agonist approved by the U.S. FDA, and it also represents the first new class of glucose-lowering drugs to be approved for marketing in nearly a decade.

Obesity is a chronic disease that affects the health of nearly 100 million Americans., is an important driver of medical costs.Although diet control and exercise are important steps, most patients cannot achieve their treatment goals through diet control and exercise alone.. In the Phase 3 SURPASS global clinical development program,Compared with all controls, type 2 diabetes patients treated with tirzepatide experienced significant weight loss.. In the Phase 3 SURMOUNT-1 clinical trial (NCT04184622),Nearly two-thirds of patients receiving the highest dose of tirzepatide lost at least 20% of their body weight.

Fast Track Designation (FTD) aims to accelerate the development and expedite the review of drugs for serious conditions, addressing critical areas of significant unmet medical need. Obtaining Fast Track Designation for an investigational drug means that pharmaceutical companies can engage in more frequent interactions with the FDA during the R&D phase. If relevant criteria are met after submitting a marketing application, the drug is eligible for accelerated approval and priority review, as well as rolling review.

Based on discussions with the FDA, Eli Lilly plans to initiate a rolling submission of a New Drug Application (NDA) for tirzepatide this year, intended for the treatment of adult patients with obesity or overweight. The application will primarily be based on the results of two Phase 3 clinical trials: SURMOUNT-1 (NCT04184622, completed) and SURMOUNT-2 (NCT04657003, expected to be completed by the end of April 2023). A rolling submission allows Eli Lilly to submit completed sections of the NDA for FDA review without waiting for all sections to be finalized before submitting the entire NDA. If the results of the SURMOUNT-2 trial are positive, Eli Lilly aims to complete the NDA submission shortly after the availability of SURMOUNT-2 data. Fast Track designation, along with the rolling submission process, will accelerate the pathway for tirzepatide’s submission to the FDA.

Tirzepatide (LY3298176, image sourced from the literature: PMID-31686879)

Tirzepatide is a novel, once-weekly dual agonist of glucose-dependent insulinotropic polypeptide (GIP, also known as gastric inhibitory polypeptide) receptor and glucagon-like peptide-1 (GLP-1) receptor developed by Eli Lilly and Company.Tirzepatide is a single molecule that activates the GIP and GLP-1 receptors in the human body. GIP and GLP-1 are both natural incretin hormones that can promote insulin secretion.Tirzepatide integrates the two insulinotropic actions into a single molecule, representing a new class of drugs for the treatment of type 2 diabetes.

GIP can complement the effects of GLP-1 receptor agonism.GIP has been shown to reduce food intake while attenuating metabolic adaptive responses, which typically occur with calorie restriction and lead to weight loss. When combined with GLP-1 receptor agonism, it may have a greater impact on markers of metabolic dysfunction such as body weight, glucose, and lipids.Currently, tirzepatide is in Phase 3 clinical development for the treatment of obese or overweight adult patients with weight-related comorbidities.

In addition to type 2 diabetes and obesity/overweight, tirzepatide is also being developed:For the treatment of heart failure with preserved ejection fraction (HFpEF), obstructive sleep apnea (OSA), and nonalcoholic steatohepatitis (NASH). In addition, Eli Lilly and Company also plans to conduct treatment with tirzepatideChronic Kidney Disease (CKD) and Obesity Incidence/MortalityConduct research.

In May 2022, Mounjaro received approval from the U.S. FDA as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D). Notably, Mounjaro is the first and only GIP/GLP-1 receptor agonist approved by the U.S. FDA, and it represents the first new class of diabetes medication to be approved for marketing in nearly a decade. In the phase 3 SURPASS global clinical development program,Compared with all controls, tirzepatide provided superior and consistent blood glucose (A1C) reduction.In addition, for key secondary endpoints, compared with all controls,Tirzepatide Treatment GroupShowed significantly greater weight loss. (Bioon.com)

Source: Eli Lilly and Company receives U.S. FDA Fast Track designation for tirzepatide for the treatment of adults with obesity, or overweight with weight-related comorbidities