The FDA ( Food and Drug Administration ) has approved Mounjaro ( Tirzepatide ) injection, new once-weekly GIP ( glucose-dependent insulinotropic polypeptide ) and GLP-1 ( glucagon-like peptide-1 ) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with 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 mellitus.
As the first and only FDA-approved GIP and GLP-1 receptor agonist, Mounjaro is a single molecule that activates the body's receptors for GIP and GLP-1, which are natural incretin hormones.
Mounjaro is available in six doses ( 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg ), using an auto-injector pen with a pre-attached, hidden needle.
The approval was based on results from the phase 3 SURPASS program, which included active comparators of injectable Semaglutide 1 mg, Insulin glargine and Insulin degludec.
Efficacy was evaluated for Mounjaro 5 mg, 10 mg and 15 mg used alone or in combination with commonly prescribed diabetes medications, including Metformin, SGLT2 inhibitors, sulfonylureas and Insulin glargine.
Participants in the SURPASS program achieved average A1C reductions between 1.8% and 2.1% for Mounjaro 5 mg and between 1.7% and 2.4% for both Mounjaro 10 mg and Mounjaro 15 mg.
While not indicated for weight loss, mean change in body weight was a key secondary endpoint in all SURPASS studies.
Participants treated with Mounjaro lost between 12 lb ( 5 mg ) and 25 lb ( 15 mg ) on average.
Side effects reported in at least 5% of patients treated with Mounjaro include nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.
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 ( MEN ) syndrome type 2. ( Xagena )
Source: Lilly, 2022