FDA Approves Zepbound, A Drug Like Ozempic, for Weight Loss. Here’s What to Know.

The choice by the Food and Drug Administration on Wednesday to approve the weight loss drug tirzepatide provides a potent new software to the fast-growing arsenal of weight problems medication.

The drug, which can go by the model identify Zepbound, accommodates the identical compound within the sought-after diabetes drug Mounjaro. Many individuals have used Mounjaro off-label to lose weight because it was initially accepted in May 2022, however the transfer may pave the way in which for insurance coverage protection and open the floodgates for extra prescriptions.

Zepbound is the second drug in a brand new class of weight problems drugs to be accepted for weight loss, following Wegovy. And it’s now seemingly the simplest therapy to fight weight problems moreover bariatric surgical procedure, mentioned Dr. Scott Hagan, an assistant professor of drugs on the University of Washington. But for many, Mounjaro has been hard to find within the 12 months because it hit the market.

“It’s very similar to what we went through with Ozempic,” mentioned Dr. Andrew Kraftson, a medical affiliate professor within the division of metabolism, endocrinology and diabetes at Michigan Medicine, noting that demand for weight loss drugs has hit a “fever pitch.” Now, he mentioned, sufferers will seemingly be clamoring for this new drug. Here’s what to know.

The F.D.A. accepted Zepbound for individuals who have a body mass index — a much-criticized metric — of 30 or better, which technically qualifies them as having weight problems, or these with a B.M.I. of 27 who even have sure weight-related situations, resembling high blood pressure. Regulators mentioned the drug must be utilized in mixture with a diminished calorie food regimen and elevated bodily exercise.

Zepbound, made by Eli Lilly, is the model identify for tirzepatide when used for weight loss. When the drug is prescribed for diabetes, it’s bought below the model identify Mounjaro.

Like semaglutide, the compound in Ozempic and Wegovy, tirzepatide slows down the emptying of the abdomen. People really feel fuller, faster and for longer. All three medication additionally goal the realm of the mind that regulates urge for food, blunting cravings for many individuals.

Semaglutide simulates a single hormone within the body, whereas tirzepatide mimics two, which consultants say could also be why it’s usually simpler at triggering weight loss. In a 72-week clinical trial, funded by Eli Lilly, members with weight problems taking the best dose of tirzepatide misplaced round 18 p.c of their body weight on common.

Not everybody reacts to these drugs in the identical manner — somebody would possibly lose little to no weight on semaglutide, however shed kilos on tirzepatide, and vice versa, mentioned Dr. Janice Jin Hwang, the division chief of endocrinology and metabolism on the University of North Carolina School of Medicine. People whose weight loss could also be most carefully tied to different health outcomes — resembling these in danger for coronary heart failure or liver illness — might profit extra from shedding a big quantity of weight on a drug like Zepbound.

But some individuals can lose an excessive amount of weight taking these medication, Dr. Hwang cautioned. Older individuals, particularly, must be conscious about their weight loss, since it could possibly lead to shrinking muscle mass. Physicians want to weigh the dangers and advantages for every affected person, she mentioned.

“There’s no guidelines around any of this,” she mentioned. “We’re just trying to think holistically about the patient.”

Coverage can differ from plan to plan, however some insurance coverage firms will seemingly cowl it for those that meet the F.D.A.’s standards. Eli Lilly said in a press release that it expects Zepbound will probably be obtainable within the U.S. by the top of the 12 months at a listing worth of $1,059.87.

In an Eli Lilly-funded research of tirzepatide for weight problems, gastrointestinal points had been the most typical unwanted side effects. Roughly one-third of members taking the best dose of tirzepatide skilled nauseaand round one-fifth skilled diarrhea. Some members additionally reported belly ache, vomiting, constipation, headache and dizziness. The F.D.A. approval states that individuals taking Zepbound might also expertise burping, hair loss and gastroesophageal reflux illness.

Because tirzepatide is so new, we have no idea a lot but about its long-term results, Dr. Hwang mentioned. And individuals taking these varieties of medicine for weight loss usually are suggested to keep on them for the remainder of their lives, she mentioned.

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