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.

Availability

The manufacturer of Zepbound, Eli Lilly, announced on Dec 8th, 2023 that it is currently available at pharmacies in the United States. This introduction marks a significant step in the availability of innovative obesity treatments.

Cost

For customers who do not have health insurance coverage for Zepbound, Eli Lilly has set the price at an approachable rate of approximately $550 per month. This pricing strategy positions Zepbound competitively, as it is roughly half of its original list price of $1060, making it more affordable for a broader range of consumers.

Weight loss injection market

Zepbound enters a rapidly expanding market dedicated to weight-loss medications. Industry analysts project that by the end of this decade, the market for such drugs is expected to burgeon, reaching a staggering value of around $100 billion. This growth reflects an increasing demand for effective obesity treatments, spurred by a rising global prevalence of obesity and a growing awareness of its health implications. Zepbound's launch into this lucrative market signifies Eli Lilly's commitment to addressing the complex challenge of obesity with advanced pharmacological solutions.

Coupons and cost savings

The manufacturer offers cost saving cards for as low as $25.00 a month with commercial insurance. Access coupons and saving cards here

Cost:Commercial Insurance with Coverage for Zepbound

If you have commercial insurance with coverage for Zepbound, you may be eligible to pay as low as $25 for a 1-month or 3-month prescription with the Zepbound Savings Card for eligible, commercially insured patients with Zepbound coverage. Governmental beneficiaries excluded. Terms and conditions apply.

Commercial insurance without coverage

If you have commercial drug insurance but it does not cover Zepbound, you may pay as low as $550 for a 1-month supply of Zepbound for a 1-month supply of Zepbound.

Zepbound clinic locator

WikiMD's weight loss clinic locator (USA)

Obesity is a complex health condition characterized by an excessive amount of body fat. Finding the right weight loss doctor is crucial for a successful obesity management plan. Need help finding a weight loss clinic in the United States that might be willing to prescribe Zepbound, Wegovy, Ozempic, Mounjaro, Saxenda or other weight loss medications such as Phentermine?

Official website

• zepbound.lilly.com

External links

• FDA approval information

Also see

• Mounjaro
• Wegovy
• Saxenda

W8MD weight loss 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 and can provide prescriptions to eligible patients.

Transform Your Life with W8MD Weight Loss Centers

W8MD offers a physician-supervised weight loss program at various locations including New York, Pennsylvania and New Jersey. Our centers provide expert medical guidance, accept most insurances, and offer telemedicine options for convenience.

Why choose W8MD?

• Comprehensive care with FDA-approved medications including:
• Weight loss injections both generic and brand names:
  • Zepbound / Mounjaro, Wegovy / Ozempic, Saxenda
• Weight loss medications including Phentermine, Qsymia, Contrave, Diethylpropion etc.
• Accept most insurances for visits or discounted self pay cost.
• Generic weight loss injections starting from just $125.00 for the starting dose
• In person weight loss NYC and telemedicine medical weight loss options in New York city available

Book Your Appointment

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