USA –The FDA announced that it has approved Eli Lilly’s injected drug tirzepatide, marketed under the brand name Mounjaro, to help improve blood sugar control in adults with type 2 diabetes.
According to the FDA, Mounjaro, when combined with diet and exercise, improved blood sugar levels and was more effective than other diabetes therapies tested in clinical trials.
Mounjaro adds to Lilly’s diabetes portfolio, which includes insulin and other therapies. Last year, the company sold US$9 billion in diabetes drugs.
Mounjaro works by stimulating two hormones that control insulin production: Glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).
In clinical trials, the drug outperformed several other diabetes medications, including one made by Novo Nordisk that only targets one hormone.
Mounjaro was also more effective than two types of insulin in controlling blood sugar. It is given once a week by injection under the skin, with the dose adjusted as tolerated to meet blood sugar goals.
According to Refinitiv, analysts expect tirzepatide sales to reach US$4.7 billion by 2026.
Similar diabetes drugs include Novo Nordisk’s Ozempic, which is also approved by the FDA as an obesity treatment under the brand name Wegovy.
Type 2 diabetes, the most common form of diabetes, is a chronic and progressive condition in which the body does not produce or use insulin normally, resulting in high blood sugar levels.
According to the FDA, more than 30 million Americans have type 2 diabetes.
The most common side effects of Mounjaro, like Trulicity and other drugs in its class, are nausea, vomiting, diarrhea, and other gastrointestinal problems.
Lilly stated that the drug will be commercialized “in the coming weeks.” According to a spokesperson, the drug’s price has yet to be announced.
The drug’s approval will increase competition between Lilly and Novo, which have been competing for market share in the United States for years.
Novo Nordisk, for example, has recently had success with Ozempic, a once-weekly shot similar to Lilly’s top-selling drug Trulicity, as well as a daily pill that works in the same way.
While the clinical trial results for Mounjaro were strongly positive, the Institute for Clinical and Economic Review, an independent drug cost watchdog, determined that there wasn’t enough evidence to prove Lilly’s drug provides a significant health benefit over Ozempic, Biopharma Dive, reports.
Novo is testing a dual-acting competitor to Mounjaro, but it is only in Phase 2 trials, trailing Lilly’s drug. Both companies are also working on developing a once-weekly insulin shot, with similar programs in Phase 3.
The next frontier for both companies is obesity, where they are attempting to demonstrate the efficacy of their drugs as weight loss treatments.
Novo has already received approval for a drug called Wegovy, and Lilly recently reported promising data for Mounjaro.
Last month, Lilly reported that a late-stage trial of tirzepatide helped obese patients lose more than 20% of their weight, prompting Wall Street to raise its sales forecast for the drug.
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