(RxWiki News) The US Food and Drug Administration (FDA) has approved a first-of-its-kind medication to treat type 2 diabetes.
This newly approved medication is called Mounjaro (tirzepatide).
The FDA approved it in combination with diet and exercise to improve blood sugar in adults with type 2 diabetes.
It is available as an injection and is to be administered under the skin once per week.
“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 Dr. Patrick Archdeacon, associate director of the FDA's Division of Diabetes, Lipid Disorders, and Obesity, in a press release.
This new approval offers an additional treatment option for the estimated 30 million-plus Americans with type 2 diabetes.
Type 2 diabetes is when the body does not make or use insulin normally, which leads to high blood sugar levels.
Tirzepatide lowers blood sugar by working on two important hormones that control blood sugar in the body. These hormones are glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).
This is the first medication of its kind to work on both of these hormones. Other type 2 diabetes medications on the market only work on GLP-1.
Tirzepatide is available in 5-milligram, 10-mg and 15-mg doses.
Tirzepatide was studied by itself and as an add-on to other diabetes medications. When compared to a few other diabetes medications, tirzepatide appeared to be more effective at improving blood sugar.
Furthermore, those who received the highest dose of tirzepatide during the study lost more weight, the FDA noted.
Potential side effects of Mounjaro included nausea and vomiting, constipation or diarrhea, reduced appetite, upper stomach discomfort and stomach pain.
As with all medications, tirzepatide presents some potential risks. Researchers did not know whether tirzepatide caused tumors, including medullary thyroid cancer, in humans. But tirzepatide has been shown to cause thyroid C-cell tumors in rats.
If you have a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2, this medication is not recommended, the FDA noted.
Tirzepatide is not approved for those with type 1 diabetes.
The FDA approved Mounjaro for Eli Lilly and Co.