© Reuters. FILE PHOTO: An Eli Lilly and Company pharmaceutical manufacturing facility at 50 ImClone Drive in Branchburg, New Jersey, March 5, 2021. REUTERS/Mike Segar/File Photo
By Patrick Wingrove and Leroy Leo
(Reuters) -The U.S. Food and Drug Administration on Wednesday approved Eli Lilly’s (NYSE:) weight-loss drug, giving the U.S. drugmaker official entry into a lucrative market that has captured Wall Street’s enthusiasm. Street this year.
The FDA approved tirzepatide for weight loss under the brand name Zepbound. It has been available as Mounjaro for type 2 diabetes since 2022 and had been increasingly used “off-label” for weight loss while approval for obesity was pending.
Zepbound will be available in the United States by the end of the year for a list price of $1,059.87, according to Lilly. That compares to a listing of $1,349 per package for Novo Nordisk’s (NYSE:) popular weight-loss drug Wegovy.
Lilly’s drug was approved for use in adults with a body mass index (BMI), a measure of weight based on height, of at least 30, or a BMI of 27 or higher if the patient also has another weight problem. weight-related health. such as heart diseases.
“Obesity and overweight are serious conditions that can be associated with some of the leading causes of death, including heart disease, stroke, and diabetes,” John Sharretts, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. .
The Indianapolis-based drugmaker said it is launching a commercial savings card program to make Zepbound cost as little as $25 for patients whose insurance agrees to cover the drug and $550 for those whose insurance does not.
Eli Lilly shares have soared 67% in 2023 on anticipation of the weight-loss drug’s approval, making it the most valuable healthcare company on the market. Although the approval was widely expected, Lilly shares rose 1.8% in afternoon trading.
Mounjaro had sales of $1.41 billion in the third quarter and Lilly acknowledged supply constraints. Following Wednesday’s FDA approval, Lilly can now promote the weight-loss drug.
Huge demand for new weight-loss treatments could support as many as 10 competing products with annual sales reaching $100 billion within a decade, mostly in the United States, industry executives and analysts said earlier this year.
The approval was based in part on data from a late-stage trial of 2,539 adults with obesity, or excess weight and weight-related medical problems, not including diabetes, as an adjunct to diet and exercise.
The most common side effects of Zepbound include nausea, diarrhea, hair loss, and gastroesophageal reflux disease, according to Lilly.
