The U.S. Food and Drug Administration (FDA) has officially given the nod to Zepbound (tirzepatide) injection for the management of chronic weight issues in adults facing obesity (with a body mass index [BMI] of 30 kilograms per square meter [kg/m2] or more) or those falling into the overweight category (BMI of 27 kg/m2 or more).
This approval is particularly aimed at individuals contending with at least one weight-related condition, such as high blood pressure, type 2 diabetes, or high cholesterol. It is designed to be used in conjunction with a reduced-calorie diet and increased physical activity.
Notably, the active ingredient in Zepbound, tirzepatide, has previously gained approval under the trade name Mounjaro for its role in enhancing blood sugar (glucose) in adults with type 2 diabetes mellitus when combined with diet and exercise.
The FDA's decision stems from the outcomes of the phase 3 SURMOUNT-1 and SURMOUNT-2 trials. In the SURMOUNT-1 trial, which involved 2,539 adults contending with obesity or excess weight-related medical problems (excluding diabetes), Zepbound users witnessed substantial weight loss over the 72-week period compared to the placebo group. Notably, those on the highest dose (15 mg) lost an average of 48 lb., while individuals on the lowest dose (5 mg) experienced an average weight loss of 34 lb., in stark contrast to the 7 lb. recorded in the placebo group.
Zepbound is slated for release in the United States by the year's end, presenting a selection of six doses (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg) at a price point of $1,059.87.
This figure reflects an approximate 20% reduction compared to the cost of semaglutide 2.4 mg injection designed for weight loss.
Importantly, the listed price doesn't accurately mirror the typical out-of-pocket expenses for patients, taking into account factors like insurance coverage and discounts. In an effort to enhance accessibility, Lilly is introducing a commercial savings card program.
For those with commercial insurance covering Zepbound, there is an opportunity to pay as little as $25 for a 1-month or 3-month prescription.
Individuals who are commercially insured but lack coverage for Zepbound may be eligible to reduce costs to as low as $550 for a 1-month prescription, offering nearly a 50% discount from the list price. The savings card program will be available for use shortly after the product becomes accessible at U.S. pharmacies.
Zepbound stimulates receptors for hormones released from the intestine, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), aiming to diminish appetite and food consumption.
Administered through a once-weekly subcutaneous injection, the dosage is gradually escalated over a period of four to 20 weeks to attain the desired levels of 5 milligrams (mg), 10 mg, or 15 mg per week. It's important to note that the highest prescribed dosage for Zepbound is 15 mg once weekly.
Around 70% of adults in the United States grapple with obesity or being overweight, and a considerable number of those falling into the overweight category also contend with conditions related to excess weight.
Scientific findings suggest that shedding 5% to 10% of body weight through dietary modifications and regular physical activity is linked to a lower risk of cardiovascular disease among adults facing the challenges of obesity or excess weight.
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