US and UK Approve Potent Weight Loss Medication

The FDA’s approval of Eli Lilly’s Zepbound marks a significant milestone for the United States in the rapidly growing global field of efficient weight loss solutions. The company has provided details on the drug’s pricing, recommended doses, insurance coverage, and its availability in stores.

Zepbound, originally introduced as a treatment for type 2 diabetes under the name Mounjaro, has now become the official brand for weight management. While the FDA granted approval for diabetes management in May 2022, it has also been commonly prescribed for weight loss despite not being officially indicated for that purpose.

UK Regulatory Authority Approves Mounjaro for Weight Management

Simultaneously with this announcement on November 8, the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK authorized the use of Mounjaro for weight management and weight loss.

Zepbound is entering the market at a time when its competitor, Denmark’s Novo Nordisk, is facing challenges in meeting the demand for Ozempic and Wegovy. To avoid potential shortages, Eli Lilly plans to double its manufacturing capacity by the end of 2023. Currently, approximately five million people in the US are officially eligible for Mounjaro, but around 50 million adults will qualify for Zepbound, with insurance covering roughly half of the cost.

Zepbound, similar to Ozempic, used for managing type 2 diabetes, and Wegovy, prescribed for obesity treatment, belongs to the class of glucagon-like peptide 1 (GLP-1) agonists. These drugs mimic a hormone to reduce food intake, slow stomach emptying, and suppress appetite. However, Zepbound’s active ingredient is tirzepatide, not semaglutide, and it mimics a second hormone called glucose-dependent insulinotropic polypeptide (GIP), which may also assist in breaking down sugar and fat in the body.

FDA Approval Based on Weight Loss Trials in 2,539 Adults

The FDA’s approval was based on trials involving 2,539 adults dealing with obesity and weight-related problems unrelated to diabetes. In these trials, which also emphasized dietary and exercise measures, participants with an average starting weight of 231 pounds (105 kilograms) lost an average of 48 pounds (22 kilograms) with the highest dose (15 mg) and 24 pounds (11 kilograms) with the lowest dose (5 mg).

Zepbound will also be administered through a pen-style injection once a week and will be offered in six different dosages: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg. Its monthly cost is set at $1,059.87, which is approximately equivalent to the price of Mounjaro and about 20% lower than the cost of Wegovy’s 2.5-mg dose.

The pharmaceutical company has introduced a commercial savings card program to improve access to this relatively expensive medication. Individuals with commercial insurance covering Zepbound may only need to pay as little as $25 for a one-month or three-month prescription. Even if Zepbound is not included in their commercial insurance plan, individuals may still qualify to obtain the drug at a subsidized rate of approximately $550 per month.

Mike Mason, the executive vice president and president of Lilly Diabetes and Obesity, emphasized the barriers preventing people with obesity from accessing effective treatments for weight loss and expressed the company’s commitment to collaborating with healthcare, government, and industry partners to ensure broader access to Zepbound for those who could benefit from it.

Gastrointestinal Side Effects Associated with Zepbound, Ozempic, and Wegovy

Similar to Ozempic and Wegovy, the use of Zepbound is associated with gastrointestinal side effects, with common symptoms including nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection-site reactions, fatigue, hypersensitivity reactions, eructation, hair loss, and gastroesophageal reflux disease.

Dr. John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, noted that obesity and being overweight are serious conditions linked to leading causes of death like heart disease, stroke, and diabetes. He highlighted the importance of the FDA’s approval to address the growing rates of obesity and overweight in the United States, emphasizing the unmet medical need for effective treatments.

Tirzepatide is presently undergoing evaluation by regulatory authorities in both Europe and China.

Additionally, the FDA is conducting an inquiry into counterfeit semaglutide products. The FDA’s Adverse Event Reporting System has received 42 reports referencing the utilization of unauthorized imitation Ozempic and Wegovy medications. According to CBS News, 28 of these reports were classified as “serious,” and three individuals have required hospitalization.

Read th e original article on: New Atlas
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