FDA Approves Mounjaro to Reduce Cardiovascular Risk in Type 2 Diabetes

en.Wedoany.com Reported - The U.S. Food and Drug Administration (FDA) has approved Mounjaro (tirzepatide) to reduce cardiovascular risk in adults with type 2 diabetes who are at high risk for major adverse cardiovascular events (MACE). MACE includes cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. The drug, a dual GIP and GLP-1 receptor agonist, was previously approved as an adjunct to diet and exercise to improve glycemic control in adults and children aged 10 years and older.

SURPASS-CVOT is the first cardiovascular outcomes trial to compare two incretin-based drugs head-to-head. This event-driven, randomized, double-blind phase 3 trial enrolled 13,299 participants at 640 sites across 30 countries, randomized 1:1, and spanned approximately five years, with a median follow-up of 210.1 weeks. For MACE-3, Mounjaro (15 mg or maximum tolerated dose) met noninferiority versus Trulicity (dulaglutide 1.5 mg), with a hazard ratio of 0.92 (95.3% CI: 0.83–1.01) and an 8% reduction in event rate; statistical superiority was not established. Full results were published in The New England Journal of Medicine.

The safety profile observed in SURPASS-CVOT was generally consistent with the known safety profile of Mounjaro, with the most common adverse events being gastrointestinal events, typically mild to moderate in severity during dose escalation. Warnings listed in the prescribing information include potential thyroid tumors, pancreatitis, risk of hypoglycemia when used with insulin or sulfonylureas, serious allergic reactions, dehydration or renal effects, gallbladder problems, and an increased risk of aspiration during anesthesia. Common side effects include nausea, diarrhea, decreased appetite, vomiting, constipation, and abdominal pain. Mounjaro is supplied as a once-weekly prefilled pen in strengths ranging from 2.5 mg to 15 mg per 0.5 mL.