U.S. officials declared on Wednesday that a new version of the well-liked diabetic therapy Mounjaro can be marketed as a medication for weight reduction.
Zepbound, a medication developed by Eli Lilly, has received FDA approval, according to AP News. In tests, the medication, also called tirzepatide, assisted dieters in losing up to 40 to 60 pounds.
Zepbound, a high-dosage variant of Novo Nordisk's Ozempic diabetic therapy, is the newest medication authorized for the control of chronic weight. These shots are given once a week.
(Photo : ROBYN BECK,RONALDO SCHEMIDT,PAUL ELLIS/AFP via Getty Images)
(FILES) This combination of file photos made on April 1, 2016 in Paris shows (From L) obese people in Los Angeles in July 30, 2003, Mexico City on May 20, 2013 and Manchester on October 10, 2006. Over one in eight adults are now obese -- a ratio that has more than doubled since 1975 and will swell to one in five by 2025, a major survey reported April 1, 2016.
For persons who are overweight and have an associated medical problem, such as high blood pressure, high cholesterol, or diabetes, or who are obese with a body mass index of 30 or greater, the FDA authorized Lilly's medication. The FDA advised using the drugs in conjunction with a low-calorie diet and frequent exercise.
Addressing the Obesity Problem in the US
At least 100 million adults and over 15 million children in the United States are classified as obese.
Tirzepatide, found in Zepbound and Mounjaro, and semaglutide, found in Wegovy and Ozempic, function by imitating hormones that are released after meals to control hunger and the sensation of fullness. They both mimic the hormone known as GLP-1, or glucagon-like peptide-1. GIP, also known as glucose-dependent insulinotropic polypeptide, is the second hormone that tirazepatide targets.
Two Big Studies
The FDA's clearance was supported by two big studies: approximately 2,500 participants received various doses of Zepbound over a 16-month period, while roughly 1,000 patients received fake injections.
When compared to placebo, those without diabetes who received the maximum dose lost almost 18% of their body weight, or about 41 pounds (19 kilograms). According to the FDA, people with diabetes, who struggle to lose weight, shed around 12% of their body weight, or close to 27 pounds (12 kg).
In a different recent trial, the medication, when paired with a strict diet and exercise regimen, assisted participants in losing up to 25% of their body weight, or 60 pounds (27 kg).
Overall, it seems that Zepbound encourages more weight reduction than Wegovy. According to study data, Wegovy, which was approved for weight reduction in 2021, assisted users in losing 34 pounds (15 kilograms), or almost 15% of their body weight.
A Growing Demand
The medications tirzepatide and semaglutide, which are promoted by celebrities and on social media, are already so popular that their producers are finding it difficult to meet demand.
Both have been available for months on the FDA's medication shortage website. Currently, tirzepatide is listed as available in all strengths; however, a business representative stated that availability may differ based on region and demand.
The novel weight-loss medication has gastrointestinal side effects such as nausea, vomiting, diarrhea, constipation, and others. In the most recent published trial, compared to around 2% of participants receiving dummy injections, over 10% of tirzepatide users withdrew from the research due to similar issues.
Although experts applauded Zepbound's clearance, they expressed concern that it would not lead to increased availability of the medication, which has been used "off-label" to assist patients lose weight.
According to Eli Lilly and Co., the list price will be the same as Mounjaro, which is almost $1,000 per month. According to the business, the medication should be accessible in the United States by year's end. Zepbound and Mounjaro have the same dosage strengths.
Related article: FDA Authorizes Active Ingredient in Drug 'Zepbound' as Weight Loss Treatment for Obese
