FDA approves tirzepatide, Eli Lilly’s new type 2 diabetes drug, and the company shares an estimated price

Tirzepatide (Mounjaro), a once-weekly injectable dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide receptor agonist (GLP-1), has been approved by the U.S. Food and Drug Administration (FDA) for improving glycemic control among adults with type 2 diabetes.

The medication, sold by Eli Lilly and Company under the name Mounjaro, will be available in six different doses and come in an auto-injector pen.

Tirzepatide was approved largely based on data from the SURPASS series of clinical trials. The research teams behind these studies found that tirzepatide was consistently linked with improvements in glycemic control and weight loss.

“Mounjaro delivered superior and consistent A1C reductions against all of the comparators throughout the SURPASS program, which was designed to assess Mounjaro's efficacy and safety in a broad range of adults with type 2 diabetes who could be treated in clinical practice,” Juan Pablo Frías, MD, medical director of the National Research Institute and a researcher involved in the SURPASS program, said in a statement. “The approval of Mounjaro is an exciting step forward for people living with type 2 diabetes given the results seen in these clinical trials.”

Patrick Archdeacon, MD, associate director of the Division of Diabetes, Lipid Disorders and Obesity within the FDA’s Center for Drug Evaluation and Research, also commented on the approval in an agency statement.

“Given the challenges many patients experience in achieving their target blood sugar goals, today’s approval of Mounjaro is an important advance in the treatment of type 2 diabetes,” he said.

Tirzepatide is not approved for patients with type 1 diabetes. In addition, Lilly emphasized in its statement, the medication has not been properly studied in patients with a history of pancreatitis.