'Twincretin' Tirzepatide Recieves FDA Approval for Type 2 Diabetes

The "Twincretin" era for treating patients with type 2 diabetes has begun, with the US Food and Drug Administration's (FDA's) approval of tirzepatide for this indication, making it the first approved agent that works as a dual agonist for the two principal human incretins.

the FDA stated that Tirzepatide represents an important advance in the treatment of type 2 diabetes, Lipid Disorders, and Obesity. That advance is based on tirzepatide's engineering, which gives it agonist properties for both the glucagon-like peptide-1 (GLP-1) receptor, as well as the glucose-dependent insulinotropic polypeptide (GIP).

The FDA's approved label includes all three dosages of tirzepatide that underwent testing in the pivotal trials: 5 mg, 10 mg, and 15 mg, each delivered by subcutaneous injection once a week. Also approved was the 2.5 mg/week dose used when starting a patient on the agent. Gradual up-titration appears to minimize possible gastrointestinal adverse effects during initial tirzepatide use.  

Tirzepatide, to be marketed by Lilly as Mounjaro, and hit the US market with much anticipation, based on results from five pivotal trials, all reported during the past year or so, that established the drug's unprecedented efficacy for reducing A1c levels as well as triggering significant weight loss in most patients with a generally benign safety profile.

Given its outstanding efficacy at both lowering glucose and weight, researchers expect tirzepatide to have quick uptake among patients with diabetes. The only limiting factor will be cost, highlighting the major stumbling block that could limit tirzepatide's uptake.