The U.S. FDA has approved Monjauro (tirzepatide), Eli Lilly’s first-in-class type 2 diabetes drug activating both glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).
“Given the challenges many patients experience in achieving their target blood sugar goals, today’s approval of Mounjaro is an important advance in the treatment of type 2 diabetes,” said Patrick Archdeacon, associate director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research.
Monjauro, which is given by injection, will be a challenge to Novo Nordisk who have cornered the GLP-1 agonist market for a number of years with blockbuster drugs such as liraglutide (Victoza), given by injection, and semaglutide (Ozempic and Rybelsus), which is available in both injectable and oral forms.
Lilly also has a GLP-1 agonist blockbuster in Trulicity (dulaglutide), but Monjauro adds a level by also activating GIP, which has a similar mechanism of action to GLP-1. Both proteins stimulate the pancreas to produce insulin and reduce blood sugar. GLP-1 also helps to reduce glucagon levels and promotes satiety, which helps patients with weight loss.
Before achieving approval, Lilly tested three different doses of Mounjaro (5, 10 and 15 mg) in five different clinical trials. Some as a stand-alone therapy and some in addition to other diabetes medications.
The researchers at Lilly tested efficacy by comparing Monjauro to placebo, semaglutide, and two long-acting insulin analogs: insulin degludec and insulin glargine. Monjauro reduced glycated hemoglobin (HbA1c) by 0.5%, 0.9% and 1.0% more than semaglutide, insulin degludec and insulin glargine, respectively.
Overweight and obesity are common issues for people with type 2 diabetes. Study participants given Monjauro lost more weight than those given other therapies. On average, weight loss with the maximum dose of Monjauro was 12 pounds more than semaglutide, 29 pounds more than insulin degludec and 27 pounds more than insulin glargine, something that could give it an edge over its competitors.
Side effects with Mounjaro included gastric problems like nausea, diarrhea, vomiting and constipation, among others. No concerning, high-grade adverse effects have been observed in participants to date, but thyroid C-cell tumors were seen in rats given the drug. As a result of this, caution is being advised in patients with a family history of this kind of cancer who are not recommended to take Mounjaro. Follow-up of study participants is also ongoing to watch for this kind of cancer and other adverse events.
Mounjaro will soon be available in the U.S. in six different doses administered by an auto-injector pen device.
