Lilly's highly anticipated diabetes drug Mounjaro wins FDA blessing

Arriving with lofty expectations, Eli Lilly’s Mounjaro (tirzepatide) got its call-up to the big leagues Friday, with the FDA greenlighting the Type 2 diabetes and weight loss med.

In a competitive market, which Novo Nordisk leads, can Lilly hit a home run with a drug that was shown in clinical trials to be more effective than other diabetes treatments?

Pegged by Evaluate Vantage to generate $4.9 billion in sales by 2026, Mounjaro emerges from a company that knows the diabetes landscape well having battled Novo Nordisk for decades.

In a head-to-head study last year, Mounjaro topped Novo’s blockbuster Ozempic, showing it was more effective in helping patients lose weight and keep their blood sugar levels in check.

More than 30 million people in the U.S. have Type 2 diabetes, with some having difficulty achieving acceptable blood sugar levels despite a wide variety of available treatments.

Mounjaro is a first-in-class, dual-action drug that activates both the glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptors. The treatment is injected once a week, with the dosage adjustable to the patient's needs.

In a phase 3 trial—where the BMI of patients averaged 32-34 and qualified them as obese—those on the highest (15-mg) dose of Mounjaro lost an average of 12 pounds more than those on Ozempic, 29 pounds more than those on insulin degludec and 27 pounds more than those on insulin glargine.

Last year, Ozempic  made 33.7 billion Danish kroner (roughly $5 billion) in sales. The drug won its FDA approval in 2017, and, in March of this year, the U.S. regulator signed off on its higher-dose version.

Lilly’s current blockbusters in the diabetes arena, Trulicity and Jardiance, generated sales of more than $10 billion last year. On Jardiance, Lilly partners with Boehringer Ingelheim.

Earlier this year, Lilly said it may market Mounjaro as a treatment for diabetes and separately for obesity. It’s a tactic that’s paid off for Novo Nordisk, which markets Ozempic as Wegovy to obesity patients.