Zepbound

FDA Approves New Weight Management Drug Zepbound

Central Obesity

Obesity waist circumference

The U.S. Food and Drug Administration (FDA) has announced the approval of Zepbound (tirzepatide) for chronic weight management in adults, signifying a pivotal step in the treatment of obesity and overweight. Specifically targeting individuals with a body mass index (BMI) of 30 kg/m² or greater, or those with a BMI of 27 kg/m² or greater who also suffer from related conditions such as high blood pressure, type 2 diabetes, or high cholesterol, Zepbound is to be used alongside a reduced-calorie diet and increased physical activity for optimal efficacy.

Background on Tirzepatide

Previously approved under the trade name Mounjaro for the improvement of blood sugar levels in conjunction with dietary and exercise regimes in adults with type 2 diabetes, tirzepatide is now set to combat weight-related health issues as the active ingredient in Zepbound.

Statement from the FDA

John Sharretts, M.D., leading the Division of Diabetes, Lipid Disorders, and Obesity within the FDA’s Center for Drug Evaluation and Research, highlights the criticality of Zepbound's approval amidst the escalating prevalence of obesity and overweight in the United States. Such conditions are linked with some of the most common causes of death, including heart disease, stroke, and diabetes.

Injection

Obesity and Overweight in the U.S.

Statistics suggest that around 70% of American adults fall into the category of obesity or overweight, with a considerable number facing weight-related health challenges. Studies advocate that reducing body weight by 5% to 10% through dietary and physical activity modifications can notably diminish the risk of cardiovascular diseases in this population.

Mechanism of Action

The drug operates by engaging receptors for intestine-secreted hormones such as Glucagon-Like Peptide-1 (GLP-1) and Glucose-Dependent Insulinotropic Polypeptide (GIP). By doing so, it effectively diminishes appetite and subsequently food intake. Administered via subcutaneous injection on a weekly basis, the dosage of Zepbound is escalated progressively, reaching target doses of 5 mg, 10 mg, or 15 mg.

Clinical Trials and Effectiveness

The efficacy of Zepbound in the realm of chronic weight management has been substantiated through two rigorous randomized, double-blind, placebo-controlled trials, involving a total of 3,477 patients. Post 72 weeks of treatment, those administered Zepbound exhibited substantial weight loss as opposed to their placebo-receiving counterparts, with a larger proportion achieving a minimum of 5% weight loss.

Results from Clinical Trials

In the most extensive non-diabetic adult trial, with an average initial weight of 231 pounds and BMI of 38 kg/m², the highest dose of Zepbound yielded an average weight reduction of 18%. In contrast, a trial focusing on adults with type 2 diabetes commenced with average weights of 222 pounds and a BMI of 36 kg/m²; here, the highest dose of Zepbound led to an average weight loss of 12%.

Side Effects and Warnings

Zepbound administration can lead to adverse effects such as nausea, diarrhea, vomiting, constipation, abdominal discomforts, and hypersensitive reactions. Furthermore, the occurrence of thyroid C-cell tumors in rat studies raises concerns, although the transference of this risk to humans remains unconfirmed. Its use is thus contraindicated in individuals with a history of specific thyroid cancers or Multiple Endocrine Neoplasia syndrome type 2.

Patients with a history of severe gastrointestinal conditions or pancreatitis, as well as those currently on GLP-1 receptor agonists, should refrain from Zepbound use. The drug's labeling also cautions against potential pancreatitis, gallbladder issues, hypoglycemia, kidney damage, diabetic retinopathy, and thoughts or behaviors of suicide.

Approvals and Designations

The FDA's Priority Review and Fast Track designations for Zepbound underscore its significant therapeutic potential and the urgency of its availability to the public.

The approval honor falls to pharmaceutical innovator Eli Lilly and Co., marking another milestone in their distinguished history.

Locations

W8MD weight loss centers is one of the first weight loss centers in the United States to announce offering Zepbound injections for weight loss, as soon as they are available.

External links

FDA approval information

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