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Today, the U.S. Food and Drug Administration approved Mounjaro (tirzepatide) injection to improve blood sugar control in adults with type 2 diabetes, as an adjunct to diet and exercise. Mounjaro was effective at improving blood sugar levels and was more effective than the other diabetes therapies it had been compared to in clinical trials.
“Given the challenges many patients experience in achieving their target blood sugar levels, the approval of Mounjaro today represents a significant 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.
Type 2 diabetes, the most common form of diabetes, is a chronic and progressive condition in which the body does not make or use insulin normally, leading to high levels of glucose (sugar) in the blood. More than 30 million Americans have type 2 diabetes. Despite the availability of many drugs to treat diabetes, many patients do not reach recommended blood sugar levels.
Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) are hormones involved in blood sugar control. Mounjaro is a premium drug that activates both GLP-1 and GIP receptors, leading to better blood sugar control. Mounjaro is given by injection under the skin once a week, with the dose adjusted to match blood sugar levels.
Three different doses of Mounjaro (5 milligrams, 10 milligrams and 15 milligrams) were evaluated in five clinical trials as a stand-alone therapy or as an adjunct to other diabetes drugs. The effectiveness of Mounjaro was compared with placebo, a GLP-1 receptor agonist (semaglutide) and two long-acting insulin analogues.
Patients randomized to receive the maximum recommended dose of Mounjaro (15 milligrams) had an average reduction in hemoglobin A1c (HbA1c) level (a measure of blood sugar control) by 1.6% more than placebo when taken as a stand-alone therapy, and 1.5% more than placebo when used in combination with a long-acting insulin. In studies comparing Mounjaro with other diabetes medicines, patients who received the maximum recommended dose of Mounjaro had their HbA1c lowered 0.5% more than semaglutide, 0.9% more than insulin degludec and 1.0% more than insulin glargine.
Obesity was common among study participants, with an average body mass index of 32 to 34 kilograms/height in square meters reported at the time of enrollment. Among patients randomized to the maximum recommended dose, the mean weight loss with Mounjaro was 15 pounds more than with placebo when neither was taken with insulin and 23 pounds more than with placebo when both were taken 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 who received insulin without Mounjaro tended to gain weight during the study.
Mounjaro may cause nausea, vomiting, diarrhea, loss of appetite, constipation, upper abdominal discomfort, and abdominal pain.
Mounjaro causes thyroid C cell tumors in rats. It is not known whether Mounjaro causes such tumors, including medullary thyroid cancer, in humans. Mounjaro 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.
Mounjaro has not been studied in patients with a history of pancreatitis (pancreatitis) and is not indicated for use in patients with type 1 diabetes.
Mounjaro has been given a priority rating for this indication. A priority rating designation draws overall attention and resources to the evaluation of applications for drugs that, if approved, would significantly improve the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions.
The FDA granted Mounjaro’s approval to Eli Lilly and Co.
The FDA, an agency within the United States Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and security of human and animal medicines, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our country’s food supply, cosmetics, nutritional supplements, products that emit electronic radiation, and for regulating tobacco products.