The US Food and Drug Administration approved the type 2 diabetes drug tirzepatide for use in chronic weight management Wednesday (Thursday AEDT), making official the use of a medicine already widely prescribed off-label for weight loss.
The drug, called Mounjaro for diabetes, will be called Zepbound for weight loss, according to a news release from the FDA. Made by Eli Lilly, it is part of a new class of drugs that includes semaglutide, known as Ozempic for diabetes and Wegovy for weight loss, which have rocketed in popularity in recent years.
Zepbound was shown in clinical trials to yield more than 20 per cent average weight loss on higher doses over 72 weeks, stronger results than what has been achieved with other approved medicines. The FDA cleared it for people with obesity or those characterized as overweight with at least one weight-related health condition, such as high blood pressure or heart disease, the same indication as for Wegovy. Like similar drugs, it is taken as a shot patients give themselves once a week, and is recommended on top of a reduced calorie diet and increased exercise.
“Obesity and overweight are serious conditions that can be associated with some of the leading causes of death such as heart disease, stroke and diabetes,” Dr John Sharretts, the FDA’s director of the Division of Diabetes, Lipid Disorders, and Obesity, said in the FDA’s news release. “In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”
The main side effects of Zepbound are gastrointestinal issues such as nausea, vomiting, constipation and diarrhoea, the FDA said. The drug’s label will contain warnings for inflammation of the pancreas, gallbladder problems, low blood sugar, acute kidney injury, diabetic retinopathy, or damage to the eye’s retina, in patients with type 2 diabetes mellitus and suicidal behavior or thinking.
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Zepbound will cost about $US1060 ($1653) a month before insurance, and will be available by the end of the year, Eli Lilly said in its own news release. Mounjaro’s list price, before insurance, is $US1023 a month.
Ozempic and Wegovy, made by Danish drugmaker Novo Nordisk, are also the same drug with different prices before insurance, although Wegovy is given at higher doses. Ozempic costs $US936 a month before insurance, while Wegovy is $US1349.
Lilly specifically highlighted in its release that Zepbound costs 20 per cent less than semaglutide for weight loss.
Lilly said in the US it would offer a savings card for patients with commercial insurance to be able to get the drug for $US25 for a one- or three-month prescription, if patients’ plans cover the medicine; if their plan doesn’t cover Zepbound, the savings card would allow them to pay $US550 for a one-month prescription.
“Far too many hurdles continue to prevent people living with obesity from accessing obesity treatments that could lead to significant weight loss,” Mike Mason, president of Lilly Diabetes and Obesity, said in the company’s release. “Broader access to these medicines is critical, which is why Lilly is committed to working with healthcare, government and industry partners to ensure people who may benefit from Zepbound can access it.”
The drugs have all been in shortage at various points, with Novo Nordisk even limiting the lower doses of Wegovy, which are prescribed to new patients, to prioritize supply of the higher doses for patients already on the medicine. Studies have shown patients may re-gain some of the weight they lost if they stop taking the medicines.
Mounjaro is still listed on the FDA’s drug shortages list, although all doses are currently labeled as available. Both Lilly and Novo Nordisk have been investing heavily in increasing manufacturing of the medicines as their use has soared.
