Eli Lilly scored another win against diabetes Friday as the company’s once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide won approval under Priority Review from the U.S. Food and Drug Administration.
Late Friday afternoon, the FDA 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. In multiple clinical studies, Mounjaro demonstrated efficacy improving blood sugar and also proved to be more effective than other diabetes therapies in clinical studies, the FDA said.
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.
Mounjaro is a first-in-class medicine that activates both the GLP-1 and GIP receptors. That activation leads to improved blood sugar control. Last year, Eli Lilly posted positive data from the Phase III SURPASS-3 trial, which showed that Mounjaro led to greater improvements in liver fat content and abdominal adipose tissue compared to titrated insulin degludec in adults with type 2 diabetes. Those results were based on magnetic resonance imaging (MRI) scans, the company said at the time.
Across multiple clinical trials, many doses of Mounjaro were assessed as either a stand-alone therapy or as an add-on to other diabetes medicines. 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. Data from the studies showed that treatment with Mounjaro saw a lowering of hemoglobin A (HbA1c) by 1.6% compared to placebo when used as a stand-alone therapy. When used in combination with insulin, the reduction was 1.5%. In head-to-head studies comparing Mounjaro to other diabetes medications, patients who received the maximum recommended dose of Mounjaro lowered their HbA1c by 0.5% more than with semaglutide, 0.9% more than insulin degludec and 1.0% more than insulin glargine, the FDA said.
In addition to lowering of blood sugar, Mounjaro also enabled 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, 29 pounds more than insulin degludec and 27 pounds more than insulin glargine. When using insulin without Mounjaro, the FDA noted that patients tended to gain weight during clinical studies.
More than 30 million Americans have been diagnosed with type 2 diabetes, a chronic and progressive disease where the body fails to make normal insulin levels, which leads to high levels of glucose in the blood. Although there are numerous treatments for diabetes, many patients fail to achieve the recommended blood sugar goals.
The FDA noted that Mounjaro can cause thyroid C-cell tumors in rats. At this time, it is unknown whether or not the Eli Lilly drug can cause such tumors, including medullary thyroid cancer, in humans.
For Lilly, the approval of Mounjaro comes two days after the FDA gave full approvalto its COVID-19 treatment Olumiant, which had previously been greenlit under Emergency Use Authorization. A Janus kinase inhibitor, Olumiant is used to treat hospitalized COVID-19 patients who require supplemental oxygen, extracorporeal membrane oxygen (ECMO), or the use of a ventilator. Olumiant was given full approval based on the Phase-III Adaptive COVID-19 Treatment Trial 2 (ACTT-2) and COV-Barrier clinical trials.
