The Food and Drug Administration (FDA) has approved tirzepatide, a weight loss drug developed by Eli Lilly, under the brand name Zepbound. The drug is already known as Mounjaro when used to treat diabetes. This approval provides an official avenue for the drug to be marketed and sold for weight loss purposes. The drug is expected to be available in the U.S. by the end of the year at a list price of $1,059.87, making it cheaper than competing drugs from Novo Nordisk.
The FDA's approval of Zepbound was based on a trial that showed participants who took the highest approved dose of tirzepatide lost an average of 18% of their body weight. The drug works by slowing down stomach emptying, making people feel fuller for longer, and targeting the brain's appetite-regulating area to reduce cravings. It is considered one of the most effective treatments for obesity, second only to bariatric surgery.
However, the availability of Mounjaro has been limited since its approval last year, leading to high demand for weight loss medications. With the approval of Zepbound, patients are expected to clamor for the new drug.
Zepbound is approved for individuals with a body mass index (BMI) of 30 or greater, categorizing them as obese, or those with a BMI of 27 and certain weight-related conditions like high blood pressure. The drug should be used in combination with a reduced calorie diet and increased physical activity.
Patients who are already taking Ozempic or Wegovy, the branded versions of semaglutide, may consider switching to Zepbound. The effectiveness of these drugs can vary from person to person, so some individuals may find better results with tirzepatide. However, physicians need to consider the risks and benefits for each patient, as losing too much weight can have negative effects, particularly in older individuals.
Insurance coverage for Zepbound will vary depending on the plan, but some companies are expected to cover the drug for those who meet the FDA's criteria. The long-term effects of tirzepatide are not yet known, as it is a new drug in this class. However, people taking weight loss medications are typically advised to continue them indefinitely.
Zepbound does come with potential side effects, including gastrointestinal issues such as nausea, diarrhea, and vomiting. Some participants in clinical trials also reported abdominal pain, constipation, and hair loss. There is also a risk of more severe side effects for individuals with a history of certain health conditions like medullary thyroid cancer or severe gastrointestinal disease. Additionally, the drug should not be combined with other GLP-1 receptor agonist drugs.
In conclusion, the approval of Zepbound as a weight loss drug provides a new option for individuals struggling with obesity. The drug's efficacy, combined with a reduced calorie diet and increased physical activity, offers hope to those seeking better weight management options. However, the availability and insurance coverage of the drug may pose challenges for some patients. The potential side effects and long-term effects of Zepbound also need to be considered by physicians and patients alike.
