The Food and Drug Administration said Friday it had approved Mounjaro, a new injection for type 2 diabetes made by Eli Lilly that lowers blood sugar and can help patients lose weight.
The agency emphasized in a press release that in clinical trials Mounjaro was more effective than other treatments that were studied.
“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,” Patrick Archdeacon, associate director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, said in a statement.
Mounjaro, also known by the generic name tirzepatide, is seen by investors as key to Eli Lilly’s fortunes and is one reason that the company’s stock is up 50% over the past year. It will compete with existing injectable drugs such as Eli Lilly’s own Trulicity and Ozempic from Novo Nordisk.
“We think that when we look back at the 2020s and 2030s, we’ll see this as a time where we started to understand that obesity can be reversed, that this can be treated like a disease,” Eli Lilly Chief Scientific Officer Daniel Skovronsky said at the company’s investment meeting in New York last December. “And when we eliminate obesity, we can prevent a huge burden of morbidity and mortality from type 2 diabetes, from cardiovascular disease, from liver disease and other ailments. This is going to be a major change in public health.”
Mounjaro’s list price was not immediately available. But Vamil Divan, an analyst at Mizuho Securities, wrote in a note to investors that based on data in both diabetes and obesity, sales of Mounjaro could approach $14 billion annually by 2030.
Existing medicines target a hormone called the glucagon-like peptide-1 that is involved in the control of blood sugar. But Mounjaro targets a second hormone, the glucose-dependent insulinotropic polypeptide, as well. It is the first medicine to target both.
The FDA said that 5 mg, 10 mg, and 15 mg doses of Mounjaro were evaluated in five different clinical trials that compared it to placebo, Ozempic, or long-acting insulins.
On average, patients randomized to receive the 15 mg dose saw their hemoglobin A1c level, a measure of blood sugar control, decrease by 1.6% more than placebo when used as the drug was used alone, and 1.5% more than placebo when Mounjaro was given on top of insulin. The 15 mg dose of Mounjaro lowered hemoglobin A1c by 0.5% more than Ozempic and by about 1% more than two common long-acting insulins.
Obesity was common in the studies, and among patients who received the 15 mg dose the average weight loss was 15 pounds more than placebo when given without insulin and 29 pounds more than placebo when patients were receiving insulin. More recent weight loss data have shown promise in patients who are obese but not diabetic.
Novo Nordisk sells the active ingredient in Ozempic under a different brand name, Wegovy, as an obesity treatment. Eli Lilly may follow a similar route in commercializing this drug.
Mounjaro can cause nausea, vomiting, diarrhea, decreased appetite, constipation, upper abdominal discomfort, and abdominal pain. It also causes thyroid tumors in rats, although the FDA said it is unknown if a similar risk would be seen in people. The medicine is not indicated for use in patients with type 1 diabetes.