Chronic weight management agent tirzepatide, marketed as Zepbound by Eli Lilly and Company, is now available through a physician’s prescription that can be filled in US retail and mail order pharmacies, according to an announcement by the manufacturer on Tuesday.1
The once-weekly injectable medication, approved by the US Food and Drug Administration in November, is indicated for adults with obesity (BMI ≥30 kg/m2), or those with overweight (BMI ≥27 kg/m2) who have at least 1 weight-related condition.2
The novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) hormone mimetic is to be prescribed as an adjunct to a reduced calorie diet and increased physical exercise.2 The first in class agent, sometimes referred to as a “twincretin,” was approved in 2022 (as Mounjaro) for the treatment of hyperglycemia in adults with type 2 diabetes and was granted FDA priority review and fast track designation for chronic weight management.3
"Today opens another chapter for adults living with obesity who have been looking for a new treatment option like Zepbound," Rhonda Pacheco, group vice president, Lilly Diabetes and Obesity, US said in the Lilly statement.1 "The availability of Zepbound in US pharmacies is the first step, but we have to work hand-in-hand with employers, government and healthcare industry partners to remove barriers and make Zepbound available to those who need it."1
The FDA based its November approval of tirzepatide labeling for chronic weight management on findings from 2 phase 3 randomized placebo-controlled clinical trials, SURMOUNT-1 and SURMOUNT-2, which each ran for 72 weeks. In both studies tirzepatide was associated with significantly greater reductions in body weight compared with placebo.3 The SURMOUNT phase 3 global clinical development program for tirzepatide for chronic weight management began in late 2019, enrolling more than 5000 participants across 6 registration studies.3
Common adverse events, which are typical of the GLP-1 receptor agonist class, included nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, injection-site reactions, fatigue, hypersensitivity reactions, burping, hair loss, and gastroesophageal reflux disease. Most gastrointestinal adverse events occurred during dose escalation and resolved over time.1
As the popularity of and demand for incretin-based antiobesity drugs like semaglutide and now tirzepatide soar, controversy deepens over their cost, which puts them out of reach for many average Americans with obesity, often despite commercial insurance coverage. In its announcement Lilly noted that tirzepatide branded as Zepbound was added to the National Preferred Formulary for both Express Scripts and Cigna Healthcare as of December 1, 2023. Effective December 15, 2023, Cigna Healthcare will add the antiobesity drug to its commercial formularies.1
Lilly also announced a commercial savings card program “to help adults who need Zepbound access it.” More information on the savings card program is available at www.Zepbound.Lilly.com.
Tirzepatide for chronic weight management is available in prefilled single-dose pens of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg and patients should be selected for treatment based on BMI, per manufacturer’s labeling.
Tirzepatide should not be used in combination with other tirzepatide-containing products or any other GLP-1 receptor agonist and the drug’s safety and efficacy when coadministered with other products for weight loss management have not been established.