FDA Approves Mounjaro for the Treatment of Diabetes in the US
The US Food and Drug Administration (FDA) has recently approved the use of the drug Mounjaro® (tirzepatide), from the pharmaceutical company Lilly, for the treatment of type 2 diabetes, according to the laboratory itself.
This GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist is a weekly injectable medication indicated along with diet and exercise to improve glycemic control in adults with diabetes type 2.
Tirzepatide will be available in six strengths (2.5mg, 5mg, 7.5mg, 10mg, 12.5mg and 15mg) and will come in Lilly’s renowned ready-to-use auto-injector pen with concealed needle. .
Tirzepatide, the first and only FDA-approved GIP and GLP-1 receptor agonist, is a single molecule that works by activating the body’s receptors for major human incretin hormones.
- It increases insulin production, but only when blood glucose increases does the risk of hypoglycemia decrease.
- Decreases hepatic (liver) glucose production.
- Decreases the rate of gastric emptying. This helps control blood glucose after eating and allows longer satiety.
The studies carried out by the pharmaceutical company, called the Surpass program , “show superior and consistent reductions in HbA1c with respect to comparator drugs in said program, designed to study the efficacy and safety of tirzepatide in adults with type 2 diabetes who are seen in clinical practice”, according to the medical director, Dr. Miriam Rubio.
The approval was based on the results of the phase 3 SURPASS program, which included active drugs with which it was compared: semaglutide injection 1 mg, insulin glargine and insulin degludec. Efficacy was evaluated for 5 mg, 10 mg, and 15 mg doses of tirzepatide alone or in combination with commonly prescribed diabetes medications, including metformin, SGLT2 inhibitors, sulfonylureas, and insulin glargine.
Participants in the SURPASS program achieved mean HbA1c reductions between 1.8% and 2.1% for tirzepatide 5 mg and between 1.7% and 2.4% for the 10 mg and 15 mg doses. Although tirzepatide is not indicated for weight loss, mean change in body weight was a key secondary endpoint in all SURPASS studies. Participants treated with tirzepatide lost between 5.4 kg (5 mg) and 11.3 kg (15 mg) on average.
Side effects reported in at least 5% of patients treated with tirzepatide include nausea, diarrhea, loss of appetite, vomiting, constipation, indigestion (dyspepsia), and stomach (abdominal) pain. The prescribing information includes a Boxed Warning for thyroid C-cell tumors. It is contraindicated in patients with a personal or family history of medullary thyroid carcinoma or in patients with Multiple Endocrine Neoplasia type 2 syndrome.
Min T, Bain SC. The Role of Tirzepatide, Dual GIP and GLP-1 Receptor Agonist, in the Management of Type 2 Diabetes: The SURPASS Clinical Trials. Diabetes Ther. 2021 Jan;12(1):143-157. doi: 10.1007/s13300-020-00981-0. Epub 2020 Dec 15. PMID: 33325008; PMCID: PMC7843845.