A Eli Lilly drug that treats diabetes and helps patients lose weight is now on the market FDA Approvedgiving drug companies a chance to scrape something else: market share of rival Novo Nordisk’s products.
The FDA on Friday approved Lilly’s drug tirzepatide to improve blood sugar control in adults with type 2 diabetes, in addition to diet and exercise. Eli Lilly’s new diabetes drug, which is injected once a week, will be marketed under the name “Mounjaro.”
Mounjaro is a peptide drug designed to activate receptors for glucagon-like peptide-1 (GLP-1) and glucose-dependent insulin trophic polypeptide (GIP), both of which are involved in blood sugar control. Indianapolis-based Eli Lilly is already marketing a GLP-1 agonist, the blockbuster drug Trulicity. Mounjaro combined this mechanism with GIP activation in one molecule.
Lilly has tested three different doses of Mounjaro in five clinical trials, either as a monotherapy or as a supplement to other diabetes medications. The studies compared Mounjaro to a placebo, Novo Nordisk’s GLP-1-activating drug Ozempic and two long-acting synthetic insulins. In placebo-controlled studies, Lilly’s drug resulted in a reduction in hemoglobin A1c, a measure of blood sugar, by an average of 1.6% as monotherapy and 1.5% when used with long-acting insulin. Eli Lilly’s drug lowered hemoglobin A1c by an average of 0.5 percent compared to Novo Nordisk’s Ozempic. The Eli Lilly drug also beat two long-acting insulins.
“Mounjaro provides superior and consistent A1C reduction compared to all comparators across SURPASS [Phase 3 clinical trial] This program is designed to evaluate the efficacy and safety of Mounjaro in adults with a broad range of type 2 diabetes who can be treated in clinical practice,” said Juan Pablo Frías, National Institute Medical Director and one of the study’s investigators, in a study prepared Good statement. “Given the results of these clinical trials, the approval of Mounjaro is an exciting advancement for people with type 2 diabetes. “
Clinical data also show that Mounjaro causes weight loss. Among those randomly assigned to receive the maximum dose without additional insulin, the patients lost 15 pounds more than those reported in the placebo group, the FDA said. When both were used with insulin, those given Mounjaro lost an average of 23 pounds more than those given a placebo. The FDA also said that at the maximum dose, patients given Mounjaro lost an average of 12 pounds more than those treated with Ozempic, and lost 29 and 27 pounds, respectively, compared to the two long-acting forms of insulin. No patients treated with Mounjaro’s insulin gained weight during the study period, the FDA said.
Weight loss could become a key feature of Eli Lilly’s new drug as the company aims to build a market for products in diabetes and beyond. Obesity is one of the other indications the company is targeting the drug.Last month, Eli Lilly released preliminary data From a placebo-controlled Phase 3 clinical trial evaluating the drug’s ability to help patients lose weight. According to the company, the highest average weight loss of the three doses tested was 52 pounds, compared with an average of 5 pounds in the placebo group. Eli Lilly’s drug is also in Phase 3 testing for heart failure and Phase 2 testing as a treatment for fatty liver disease nonalcoholic steatohepatitis.
In Mounjaro’s diabetes study, the most common adverse reactions observed included nausea, vomiting, diarrhea, decreased appetite, constipation, epigastric discomfort, and abdominal pain. The FDA noted that the Eli Lilly drug caused thyroid tumors in preclinical studies in rats. While it’s unclear whether Mounjaro causes such tumors in humans, its label carries a boxed warning about the risk and cautions that those with a family or personal history of thyroid cancer should not take the drug.
Diabetes is Eli Lilly’s largest therapeutic area by revenue, and Trulicity is the company’s best-selling product, with $6.5 billion in revenue last year, up 28% from 2020 sales. By comparison, Novo Nordisk’s Ozempic generated DKK 33.7 billion (about $4.7 billion) in 2021.
Mounjaro will be available in six different doses, administered using the company’s auto-injector pen device used in other products.Eli Lilly said It expects its new drug to be available in the next few weeks. The company has not disclosed the price of Mounjaro, a spokesman said.
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