2023-11-10 05:36:12
Dubai, United Arab Emirates (CNN) – The US Food and Drug Administration approved the use of the type 2 diabetes drug terzepatide in chronic weight management on Wednesday, making formal off-label use of an already widely prescribed drug for weight loss.
The drug, called “Mounjaro” for diabetes, will take on the name “Zepbound” for weight loss, according to a press release from the US Food and Drug Administration. Manufactured by Eli Lilly, the drug is part of a new class of drugs that includes semaglutide, known as Ozempic for diabetes and Wegovy for weight loss that have soared in popularity in recent years.
Clinical trials showed that the drug “Zepbound” leads to weight loss of more than 20% on average, at higher doses over a period of 72 weeks. These results were described as stronger than those seen with other approved drugs.
The Food and Drug Administration has approved it for people who are obese, or who are overweight and have at least one weight-related health condition, such as high blood pressure or heart disease. This is the same indication approved for the drug “Wegovy”.
Like similar medications, it is administered as a self-administered dose once a week, and it is recommended that this be accompanied by a low-calorie diet and increased exercise.
Dr. John Sharets, director of the Division of Diabetes, Lipid Disorders, and Obesity at the US Food and Drug Administration, said in a press release, “Obesity and overweight are serious conditions that may be linked to some of the leading causes of death, such as heart disease, stroke, and diabetes.” . He continued, “In light of the rising rates of obesity and overweight in the United States, today’s approval addresses an unmet medical need.”
The US Food and Drug Administration indicated that the main side effects of “Zepbound” may affect the digestive system, such as nausea, vomiting, constipation, and diarrhea. The drug label warns of the possibility of pancreatitis, gallbladder problems, low blood sugar, acute kidney injury, diabetic retinopathy, or damage to the retina, in patients with type 2 diabetes, and suicidal behavior or ideation.
For its part, the company “Eli Lilly” revealed in a press release that the drug “Zepbound” will cost regarding $1,060 per month before insurance, noting that it will be available in pharmacies following the Thanksgiving holiday.
As for the drugs “Ozempic” and “Wegovy”, produced by the Danish pharmaceutical company “Novo Nordisk”, their prices are also different before insurance, even though “Wegovy” is given in higher doses. “Ozempic” costs $936 per month before insurance, while “Wegovy” costs $1,349.
The company “Eli Lilly” was keen to point out that the cost of its drug “Zepbound” is 20% lower than the drug “semaglutide” for weight loss.
Tirzepatide mimics the hormones that stimulate insulin release, increasing feelings of fullness and reducing appetite. It targets two hormone receptors, GIP and GLP-1, while semaglutide focuses on GLP-1 only.
All drugs have different shortcomings, and Novo Nordisk has even limited the lower doses of Wegovy it is prescribed to new patients, in order to prioritize providing higher doses to patients who take the drug regularly. Studies have shown that patients may regain some of the weight they lost if they stop taking the medications.
In a press conference held on Wednesday, David Rex, CEO of Eli Lilly, pointed to the important moments in the history of the giant pharmaceutical company, as a prelude to the introduction of “Zepbound,” in a manner similar to the approval of the first commercial insulin more than a century ago, and the drug “Prozac” in in 1986, describing them as medical revolutions.
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