Lilly gets FDA fast track designation for tirzepatide in obesity

Eli Lilly and Company (Lilly) has been granted fast track designation for tirzepatide from the US Food and Drug Administration (FDA) for the treatment of adults having obesity, or are overweight with weight-associated comorbidities.

Tirzepatide is a weekly once glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist.

The American pharma giant said that based on its talks with the FDA, it intends to launch a rolling submission of a new drug application (NDA) for tirzepatide in the patient population this year.

The rolling submission when complete will be mainly based on the findings of a couple of phase 3 clinical trials, the completed SURMOUNT-1 study and SURMOUNT-2, which is likely to be over by the end of April 2023.

According to Lilly, the rolling submission enables it to file completed sections of an application for review by the US regulator, instead of waiting till the completion of all the sections.

Mike Mason — Lilly Diabetes president said: “Obesity is a chronic disease that impacts the health of nearly 100 million Americans and is a significant driver of healthcare costs. While diet and exercise are important steps, most patients don’t achieve their desired treatment goals with only diet and exercise.

“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 percent in SURMOUNT-1.”

Tirzepatide has FDA approval under the brand name Mounjaro (tirzepatide) since 13 May 2022 as an adjunct to diet and exercise to boost glycemic control in adults having type 2 diabetes mellitus.