Novel T2D Injectable Drug Approved by the FDA

Washington, D.C.—A novel, new molecular entity injectable product has been approved to treat T2D, and studies suggest it lowers blood sugar more effectively than long-acting insulin analogs and a commonly prescribed glucagon-like peptide-1 (GLP-1) receptor agonist. It should be available for distribution by summer.

The FDA approved Mounjaro (tirzepatide injection), marketed by Eli Lilly and Company, to improve blood sugar control in adults with T2D as an addition to diet and exercise.

The FDA found that tirzepatide injection was effective at improving blood sugar and was more effective than the other diabetes therapies to which it was compared in clinical studies.

"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," stated Patrick Archdeacon, MD, associate director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA's Center for Drug Evaluation and Research.

Mounjaro is a first-in-class medication that activates both GLP-1 and glucose-dependent insulinotropic polypeptide—the hormones involved in blood sugar control. It is administered by injection under the skin once weekly, with necessary dose adjustments.

Five clinical trials evaluated three different doses of Mounjaro (5 mg, 10 mg, and 15 mg) as either a stand-alone therapy or as an add-on to other diabetes medicines. In the studies, the efficacy of Mounjaro was compared with placebo, semaglutide, and two long-acting insulin analogs.

Results indicated that, on average, patients randomized to receive the maximum recommended dose of Mounjaro (15 mg) lowered their hemoglobin A1c 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 long-acting insulin.

The trials comparing Mounjaro to other diabetes medications reported that patients who received the maximum recommended dose of Mounjaro had lowering of their glycosylated hemoglobin A1C by 0.5% more than semaglutide, 0.9% more than insulin degludec, and 1.0% more than insulin glargine.

Injection of tirzepatide also appeared to foster weight loss. With obesity common among study participants, with an average BMI of 32 to 34 kg/height in meters² reported at the time of enrollment, those randomized to the maximum recommended dose had an average weight loss with Mounjaro of 15 pounds more than placebo when neither were used with insulin and 23 pounds more than placebo when both were used with insulin.

In addition, the trials reported that the average weight loss with the maximum recommended dose of Mounjaro was 12 pounds more than semaglutide, 29 pounds more than insulin degludec, and 27 pounds more than insulin glargine. The study noted that patients receiving insulin without Mounjaro tended to gain weight during the study.

The side effects of Mounjaro include nausea, vomiting, diarrhea, decreased appetite, constipation, and upper abdominal discomfort and pain. Contraindications are similar to other GLP-1 receptor agonists.

Mounjaro is expected to be available in U.S. in the coming weeks, according to Lilly's press release.

The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.