Eli Lilly’s diabetes treatment wins FDA approval

Eli Lilly’s once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide has won FDA approval.

The FDA recently approved tirzepatide to improve blood sugar control in adults with type 2 diabetes, as an addition to diet and exercise. The new diabetes treatment will be sold under the brand name Mounjaro. Mounjaro has demonstrated efficacy in improving blood sugar, and is also proven to be more effective than other diabetes therapies in clinical studies, according to the FDA.

Mounjaro is a first-in-class medicine that activates both the GLP-1 and GIP receptors. That activation leads to improved blood sugar control.

The treatment was assessed as either a stand-alone therapy, or as an add=on to other diabetes medicines across multiple clinical trials. The efficacy of the dual-acting drug was compared to placebo, a GLP-1 receptor agonist (Novo Nordisk’s semaglutide), as well as two long-acting insulin analogs.

As well as lowering blood sugar, Mounjaro also enables patients to lower their weight by 15 to 23 pounds. Compared to other diabetes drugs, the FDA said the average weight loss with the maximum recommended dose of Mounjaro was 12 pounds more than semaglutide.  

Patrick Archdeacon, associate director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, called the approval of Mounjaro an “important advance in the treatment of type 2 diabetes” given the challenges many patient face in attempting to achieve target blood sugar goals.

Lina Adams