Mounjaro (tirzepatide), Eli Lilly’s Highly Awaited Type 2 Diabetes Injection Gets FDA Nod

Mounjaro (tirzepatide), Eli Lilly’s Highly Awaited Type 2 Diabetes Injection Gets FDA Nod

With its FDA approval, Eli Lilly’s Mounjaro is set to take on Novo Nordisk’s blockbuster diabetes shot Ozempic.

Eli Lilly’s diabetes and weight loss shot tirzepatide, known by its trade name Mounjaro, received a much-anticipated nod from the US Food and Drug Administration (FDA) last week for the treatment of diabetes. The injection is intended to regulate blood sugar, in conjunction with diet and exercise, in adults with type 2 diabetes.

While the drug is also being investigated for weight loss, having shown to reduce body weight by an average of 20 percent in recent results from an ongoing study, its recent approval is only for diabetes treatment.

And that is a big win for Lilly as it looks to take on diabetes drug rival Novo Nordisk, which currently dominates the market with its diabetes injection Ozempic (semaglutide). Life science industry data analytics company Evaluate Vantage predicts that Mounjaro could bring in $4.9 billion in sales for Lilly by 2026.

It is also a major win for type 2 diabetes patients as Mounjaro can help with both blood sugar management and weight loss, making it a great advancement in the diabetes space.

Novo Nordisk markets a higher-dose version of Ozempic called Wegovy for weight loss for obesity patients, and it is expected that Lilly may do the same with Mounjaro.

Mounjaro is a once-a-week injection that is administered under the skin. The dose is adjusted as tolerated to meet blood sugar goals.

Related: Tirzepatide Obesity Drug Shown to Reduce Body Weight by 20 Percent in Eli Lilly Trial

Mounjaro has a dual-action design as it mimics the action of two hormones involved in blood sugar control, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), making it the first-in-class medicine that activates both of the receptors.

Novo Nordisk’s Ozempic is a GLP-1 receptor agonist and in a head-to-head trial last year, Lilly’s drug trumped Novo’s. The study showed that Mounjaro was more effective at controlling blood sugar and helping patients lose weight than Ozempic.

Mounjaro’s FDA approval was based on data from five clinical trials either as a single therapy or in combination with other diabetes medications. The efficacy of Mounjaro was compared to placebo, Novo Nordisk’s semaglutide and two long-acting insulin analogs.

Results of the studies showed that patients who randomly received 15 mg of Mounjaro, which is the maximum recommended dose, had 1.6 percent lower hemoglobin A1c (HbA1c) levels than placebo when used as a standalone treatment and 1.5 percent more than placebo when used in combination with a long-acting insulin.

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In trials involving other diabetes medications, patients who received Mounjaro had lowering of HbA1c by 0.5 percent more than semaglutide, 0.9 percent more than insulin degludec and 1.0 percent more than insulin glargine.

Many of the individuals in the studies were obese as they had a body mass index (BMI) between 32 to 34, on average. With respect to weight loss, the maximum recommended dose of Mounjaro resulted in participants losing an average of 15 pounds more than placebo when neither were used with insulin and 23 pounds more than placebo when both were used with insulin.

Individuals who received Mounjaro lost an average of 12 pounds more than those who were taking Ozempic, 29 pounds more than those who took insulin degludec and 27 pounds more than those who were on insulin glargine. Patients who received insulin without Mounjaro tended to gain weight during the study.

“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, MD, associate director of the Division of Diabetes, Lipid Disorders and Obesity in the FDA’s Center for Drug Evaluation and Research (CDER).

Trulicity and Jardiance (developed jointly with Boehringer Ingelheim) are Lilly’s other diabetes blockbusters, which totalled sales of more than $10 billion last year.