The US Food and Drug Administration has approved Zepbound (tirzepatide) injection for chronic weight management alongside a reduced calorie diet and increased physical activity.
It is approved in adults with obesity (body mass index of 30 kilograms per square meter (kg/m2) or greater) or overweight (body mass index of 27kg/m2 or greater) with at least one weight-related condition (such as high blood pressure, type 2 diabetes or high cholesterol) for use.
Tirzepatide, the active ingredient in Zepbound, is already approved under the trade name Mounjaro to be used along with diet and exercise to help improve blood sugar (glucose) in adults with type 2 diabetes mellitus.
“Obesity and overweight are serious conditions that can be associated with some of the leading causes of death such as heart disease, stroke and diabetes,” said John Sharretts, Director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”
The drug has also been approved (as Mounjaro) for weight loss by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
Julian Beach, MHRA Interim Executive Director, Healthcare Quality and Access, said: “We have prioritised rapid assessment of this new indication for Mounjaro, given the public health importance of access to new medicines to help tackle obesity. We have drawn on advice from the independent Commission on Human Medicines in coming to our decision, and as with all products, will keep the safety of Mounjaro under close review.”
Novo Nordisk’s competitor weight loss drug Wegovy was recently shown to reduce the risk of major adverse cardiovascular events (MACE) by 20%.
Greater weight loss with tirzepatide
Zepbound activates receptors of hormones secreted from the intestine (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)) to reduce appetite and food intake. Zepbound is administered by injection and the dosage must be increased over four to 20 weeks to achieve the target dosages of 5mg, 10mg or 15mg once weekly.
Zepbound’s effectiveness for chronic weight management was established in two randomised, double-blind, placebo-controlled trials of adults with obesity or overweight with at least one weight-related condition.
In both trials, after 72 weeks of treatment, a greater proportions of patients who received Zepbound achieved at least 5% weight reduction compared to placebo.
The larger of the two trials enrolled 2,539 adults without diabetes (SURMOUNT-1). In this trial, those who received the highest approved dosage of Zepbound (15mg once weekly) lost on average 18% more body weight compared to placebo.
In the trial in adults with type 2 diabetes (SURMOUNT-2), those who received 15mg of Zepbound lost on average 12% more body weight compared to placebo. Read more about the SURMOUNT-2 trial.
Diana Spencer, Senior Digital Content Editor, DDW