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

Posted: 05/19/2022

The FDA recently approved Mounjaro (tirzepatide) injection to improve blood sugar control in adults with type 2 diabetes, as an addition to diet and exercise. Mounjaro is the first and only approved single molecule that activates the glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors in the body. In clinical studies, Mounjaro was effective at improving blood sugar and was more effective than the other diabetes therapies with which it was compared.  

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 to placebo, a GLP-1 receptor agonist (semaglutide), and two long-acting insulin analogs. See the trial results in the table below.

Additional information:

  • Mounjaro is a single-dose prefilled pen administered by injection under the skin once weekly, with the dose adjusted as tolerated to meet blood sugar goals.
  • Mounjaro can cause nausea, vomiting, diarrhea, decreased appetite, constipation, upper abdominal discomfort, and abdominal pain.
  • 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 pancreas inflammation (pancreatitis), and it is not indicated for use in patients with type 1 diabetes.

Click here to read more about the approval.

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