FDA approval of Zepbound (Tirzepatide) for Chronic Weight Management - Summary
Introduction
In a significant advancement for chronic weight management, the U.S. Food and Drug Administration (FDA) recently approved Zepbound (tirzepatide) injection. This announcement is relevant for individuals seeking a weight loss doctor in Vancouver because Health Canada would likely follow the FDA’s lead shortly, making tirzepatide an ‘on-label’ medication for Obesity in Canada as well. Tirzepatide, the active ingredient in Zepbound, is already approved and available in Canada under the trade name Mounjaro to be used along with diet and exercise to improve blood sugar in adults with type 2 diabetes.
Zepbound’s Approval and Use
Zepbound has been approved for use in adults with obesity (body mass index (BMI) of 30 kg/m2 or greater) or overweight (BMI of 27 kg/m2 or greater) accompanied by at least one weight-related condition like high blood pressure, type 2 diabetes, or high cholesterol. This prescription is in addition to a reduced-calorie diet and increased physical activity. Tirzepatide, the active ingredient in Zepbound, is also known under the trade name Mounjaro for type 2 diabetes management, with many US doctors having already been prescribing the medication “off-label” for obesity.
The Significance of Zepbound’s Approval
John Sharretts, M.D., from the FDA highlights the approval's importance due to the rising rates of obesity and overweight in the U.S. With approximately 70% of American adults classified as obese or overweight, many of whom have weight-related conditions, Zepbound addresses a critical medical need.
How Does Zepbound Work?
Zepbound activates receptors of hormones secreted from the intestine - namely glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) - to reduce appetite and food intake. Zepbound is administered by injection subcutaneously once weekly, and the dosage must be increased over four to 20 weeks to achieve the target dosages of 5 milligram (mg), 10 mg or 15 mg once weekly
Clinical Trials and Effectiveness
The effectiveness of Zepbound for chronic weight management was proven in two major trials, showing significant weight reduction over 72 weeks compared to placebo. In one trial, participants without diabetes lost an average of 18% body weight with the highest Zepbound dosage. Those with type 2 diabetes experienced an average weight loss of 12% at the same dosage.
Side Effects and Precautions
Zepbound can cause side effects such as nausea, diarrhea, vomiting, constipation, abdominal discomfort, injection site reactions, fatigue, hypersensitivity (allergic) reactions (typically fever and rash), burping, hair loss and gastroesophageal reflux disease. It's not recommended for patients with certain medical histories like medullary thyroid cancer or severe gastrointestinal diseases. Additionally, its interaction with other weight management medications has not been fully studied.
Conclusion
For those consulting a weight loss doctor in Vancouver, Zepbound will not yet be available for managing obesity and overweight. However, it has already been approved and is available in Canada for the management of diabetes under the trade name Mounjaro. This FDA approval marks a step forward in addressing the growing need for effective weight management solutions.