FDA Okays Lilly’s Novel Diabetes Drug

The FDA has approved Eli Lilly’s Mounjaro (tirzepatide) injection — the first drug of its type — to treat type 2 diabetes. Mounjaro has not been studied in patients with a history of pancreatitis and is not indicated for use in patients with type 1 diabetes.

The once-weekly GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist is the first and only FDA-approved GIP and GLP-1 receptor agonist, Lilly said in a news release.

Mounjaro will be available in six doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg) and will come in Lilly's auto-injector pen with a pre-attached, hidden needle.

Mounjaro was effective at improving blood sugar and was more effective than the other diabetes therapies with which it was compared in clinical studies. The FDA said in a news release.

“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,” Patrick Archdeacon, M.D., associate director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said in the press release.

Juan Pablo Frías, M.D.

The approval of Mounjaro is “an exciting step forward for people living with type 2 diabetes given the results seen in these clinical trials," said Juan Pablo Frías, M.D., medical director at the National Research Institute and investigator in the SURPASS program, the clinical trials assessing Mounjaro in type 2 diabetes.

Three different doses of Mounjaro (5 mg, 10 mg and 15 mg) were evaluated in five clinical trials, as either a stand-alone therapy or as an add-on to other diabetes medicines. The efficacy of Mounjaro was compared with placebo, a GLP-1 receptor agonist (semaglutide, brand names Ozempic, Wegovy) and two long-acting insulin analogs.

On average, patients randomized to receive the maximum recommended dose of Mounjaro (15 mg) realized lowering of their hemoglobin A1c (HbA1c) level by 1.6% more than placebo when used as stand-alone therapy, and 1.5% more than placebo when used in combination with a long-acting insulin.

In trials comparing Mounjaro with other diabetes medications, patients who received the maximum recommended dose of Mounjaro had lowering of their HbA1c by 0.5% more than semaglutide, 0.9% more than insulin degludec and 1.0% more than insulin glargine, the FDA said.

In addition, among patients randomized to the maximum recommended dose, the average weight loss with Mounjaro was 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 Mounjaro was 12 pounds more than semaglutide, 29 pounds more than insulin degludec and 27 pounds more than insulin glargine. Those patients receiving insulin without Mounjaro tended to gain weight during the study.

The labeling for Mounjaro contains a Boxed Warning regarding thyroid C-cell tumors. Mounjaro is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia syndrome type 2, Lilly said.

Mounjaro can cause nausea, vomiting, diarrhea, decreased appetite, constipation, upper abdominal discomfort and abdominal pain, according to the FDA.