FDA Approves Lilly’s Novel, Dual-Targeted Treatment for Type 2 Diabetes

FDA announced on May 13, 2022 that it has approved Eli Lilly and Company’s Mounjaro (tirzepatide) injections as a once-weekly treatment for adults with type 2 diabetes to help manage blood sugar levels. Tirzepatide is a first-in-class medicine that activates both the glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptors, which ultimately leads to improved blood sugar control.

The approval follows five clinical trials wherein three different doses of tirzepatide (5 mg, 10 mg, and 15 mg) were evaluated as either a stand-alone therapy or as an add-on to other diabetes medicines. On average, the patients randomized to receive the maximum recommended dose of 15 mg had a lowering of their hemoglobin A1c level by 1.6% more than placebo when used as a stand-alone therapy, and by 1.5% when used as an add-on. Trials comparing it to other medicines found that it lowered levels by 0.5% more than semaglutide, 0.9% more than insulin degludec, and 1.0% more than insulin glargine.

Additionally, the study found that participants (largely obese, with an average body mass index measured between 32 and 34 at the time of enrollment) in the tirzepatide groups lost more weight than other treatments. Patients lost 15 pounds more than placebo when neither were used with insulin and 23 pounds more than placebo when both were used with insulin. The average weight loss with the maximum recommended dose of tirzepatide was 12 pounds more than semaglutide, 29 pounds more than insulin degludec, and 27 pounds more than insulin glargine. Patients who received insulin without tirzepatide tended to gain weight during the study.

“Given the challenges many patients experience in achieving their target blood sugar goals, today’s approval of [tirzepatide] is an important advance in the treatment of type 2 diabetes,” said Patrick Archdeacon, associate director of the Division of Diabetes, Lipid Disorders, and Obesity, FDA’s Center for Drug Evaluation and Research, in the agency’s press release.

Tirzepatide causes thyroid C-cell tumors in rats. It is unknown whether tirzepatide causes such tumors, including medullary thyroid cancer, in humans, but FDA states that it should not be used in patients with a personal or family history of medullary thyroid cancer or in patients with multiple endocrine neoplasia syndrome type 2. Reported side effects include nausea, vomiting, diarrhea, decreased appetite, constipation, upper abdominal discomfort and abdominal pain.

Source: FDA