The U.S. Food and Drug Administration has granted approval for Zepbound (tirzepatide) injection for managing chronic weight issues in adults struggling with obesity or overweight. Aimed at individuals with a Body Mass Index (BMI) of 30 kg/m2 or greater for obesity and 27 kg/m2 or greater for overweight, Zepbound is designed for those with at least one weight-related medical problem, such as hypertension, type 2 diabetes, or high cholesterol. It is to be combined with a reduced-calorie diet and increased physical activity. Tirzepatide, the active component in Zepbound, is already sanctioned under the trade name Mounjaro for assisting in the improvement of blood sugar in adults dealing with type 2 diabetes mellitus.
Indications and Competitors
Competitors in this domain include several medications used for weight management, such as semaglutide, liraglutide, and orlistat. These medications have been utilized in varying capacities to assist in weight reduction and maintenance for individuals dealing with obesity or related conditions. Zepbound stands out for its unique mechanism of action in activating both GIP and GLP-1 receptors, unlike its competitors, which predominantly focus on GLP-1 activation.
Video from: https://www.washingtonpost.com/health/2023/11/08/mounjaro-zepbound-fda-approval-obesity/
The FDA has approved Zepbound for adults with a Body Mass Index (BMI) of 30 kg/m² or greater for obesity, or a BMI of 27 kg/m² or greater for overweight individuals, who have at least one weight-related condition, such as high blood pressure, type 2 diabetes, high cholesterol, obstructive sleep apnea, or cardiovascular disease. As an adjunct to a reduced-calorie diet and increased physical activity, these individuals can benefit from Zepbound to lose weight and maintain a healthier lifestyle.
Dr. John Sharretts, the director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, expressed the critical importance of this approval, addressing an unmet medical need as obesity and overweight are increasingly prevalent in the United States. Statistics show that roughly 70% of American adults are either obese or overweight, with many experiencing weight-related conditions. Scientific evidence indicates that reducing body weight by 5% to 10% through dietary changes and exercise is associated with lower cardiovascular disease risk among individuals facing obesity or overweight challenges.
Zepbound operates by stimulating receptors of intestinal hormones such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), effectively curbing appetite and reducing food intake. Administered via subcutaneous injection once weekly, the dosage is gradually increased over four to 20 weeks to reach the target dosages of 5 mg, 10 mg, or a maximum of 15 mg weekly.
Trials and Efficacy Results
The efficacy of Zepbound in chronic weight management, aimed at weight reduction and maintenance along with a reduced-calorie diet and increased physical activity, has been established through two randomized, double-blind, placebo-controlled trials. A total of 2,519 patients who received Zepbound and 958 patients who received weekly placebo injections were involved. In both trials, patients receiving Zepbound at all three dose levels experienced a statistically significant reduction in body weight compared to those who received placebos. Additionally, a higher proportion of Zepbound recipients achieved at least a 5% weight reduction compared to those on placebos.
The larger of the two trials enrolled adults without diabetes. The starting average body weight of participants was 231 pounds (105 kg), with an average body mass index of 38 kg/m2. In this segment of the trial, those administered with the highest approved Zepbound dosage of 15 mg weekly lost an average of 18% of their body weight compared to the placebo group.
In the trial involving adults with type 2 diabetes, the average starting weight was 222 pounds (101 kg), and the average body mass index was 36 kg/m2. Here, those receiving the highest approved dose of Zepbound (15 mg weekly) experienced an average weight reduction of 12% compared to those on placebos.
Adverse Effects and Precautions
Zepbound may lead to side effects including nausea, diarrhea, vomiting, constipation, abdominal discomfort and pain, injection site reactions, fatigue, hypersensitivity reactions, burping, hair loss, and gastroesophageal reflux disease. Notably, Zepbound has been shown to cause thyroid C-cell tumors in rats; however, its impact on humans, including medullary thyroid cancer, remains unknown. Precautionary measures include avoiding use in patients with a history of medullary thyroid cancer, Multiple Endocrine Neoplasia syndrome type 2, pancreatitis, or severe gastrointestinal disease. It is not to be used in combination with Mounjaro or a GLP-1 receptor agonist.
Zepbound has not been studied in patients with a history of pancreas inflammation (pancreatitis) or severe gastrointestinal disease. It should not be used in combination with Mounjaro or a GLP-1 receptor agonist. The safety and effectiveness of coadministration of Zepbound with other medications for weight management have not been established.
Patients are advised to immediately stop using Zepbound and seek medical help if severe allergic reactions are suspected. Furthermore, Zepbound has warnings concerning pancreatitis, gallbladder problems, hypoglycemia, acute kidney injury, diabetic retinopathy in patients with type 2 diabetes mellitus, and suicidal behavior or thinking. Monitoring by healthcare providers is recommended for patients with kidney disease, diabetic retinopathy, depression, or suicidal behaviors or thoughts.
Conclusion
The approval of Zepbound (tirzepatide) by the FDA stands as a significant advancement in chronic weight management, introducing a unique treatment approach for adults grappling with obesity and weight-related medical conditions. Its distinction lies in the activation of both GIP and GLP-1 hormone receptors, offering a new paradigm in addressing the unmet medical need posed by rising obesity rates. While Zepbound shows promise, careful consideration of its potential side effects and contraindications is essential, and its efficacy in comparison to other available medications warrants further exploration. This approval not only provides hope for those seeking alternative weight management options but also encourages ongoing innovation and research in the pursuit of more effective and safe obesity treatments.
References:
U.S. Food and Drug Administration. FDA Approves New Medication for Chronic Weight Management [Internet]. [Place of publication]: U.S. Food and Drug Administration; [Date accessed: 2023 Nov 8]. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-new-medication-chronic-weight-management#:~:text=Today%2C%20the%20U.S.%20Food%20and,weight%2Drelated%20condition%20(such%20as.
Lilly. FDA Approves Lilly’s Zepbound™ (tirzepatide) for Chronic Weight Management, a Powerful New Option for the Treatment of Obesity or Overweight with Weight-Related Medical Problems [Internet]. Lilly; 2023 Nov 8 [cited 2023 Nov 8]. Available from: https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-zepboundtm-tirzepatide-chronic-weight.
Bernstein L. FDA approves Eli Lilly’s Mounjaro and Zepbound for obesity. The Washington Post [Internet]. 2023 Nov 8. Available from: https://www.washingtonpost.com/health/2023/11/08/mounjaro-zepbound-fda-approval-obesity/
Zepbound™ (tirzepatide) injection. Eli Lilly and Company. [cited 2023 Nov 08]. Available from: https://www.zepbound.lilly.com/?redirect-referrer=https://www.google.com/
Time. FDA Approves New Medication for Chronic Weight Management. [cited 2023 Nov 08]. Available from: https://time.com/6333255/fda-approval-zepbound-tirzepatide-mounjaro-weight-loss/
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