FDA Approves Tirzepatide for Patients With Type 2 Diabetes

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The approval represents the first in-class treatment that activates both GLP-1 and GIP.

The US Food and Drug Administration (FDA) has approved tirzepatide (Mounjaro) injection, a novel, dual-targeted treatment to improve blood sugar control in adults with type 2 diabetes.

“Type 2 diabetes is a chronic and progressive condition that requires continued innovation to help people manage their blood glucose and weight," Mike Mason, president, Lilly Diabetes, said in a statement. "Today’s FDA approval underscores our commitment to the discovery and development of new treatment pathways, and we are thrilled to bring this new and innovative treatment option to people living with type 2 diabetes.”

The treatment, developed by Eli Lilly and Co., is to be used as an addition to diet and exercise, representing the first in-class treatment that activates both the glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).

Clinical trial results show the drug is effective at improving blood sugar more effectively than other diabetes therapies. A total of 3 doses (5 mg, 10 mg, and 15 mg) of the treatment were evaluated in a total of 5 clinical trials.

The drugs were tested as either a stand-alone therapy or as an add-on to other medications.

The 15 mg dose resulted in the lowering of hemoglobin A1c (HbA1c) level by 1.6% more than placebo when used as a stand-alone therapy and 1.5% more than placebo when used in combination with a long-acting insulin. This dose also resulted in the lowering of HbA1c by 0.5% more than semaglutide, 0.9% more than insulin degludec, and 1.0% more than insulin glargine.

Treatment with tirzepatide also resulted in an average weight loss of 15 pounds more than placebo when both were used with insulin, with an average weight loss with the 15 mg dose of 12 pounds more than semaglutide, 29 pounds more than insulin degludec and 27 pounds more than insulin glargine.

“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,” said Patrick Archdeacon, MD, associate director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, in a statement.