What you need to know about Mounjaro, the next breakthrough drug awaiting FDA approval to treat weight loss

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  • Tirzepatide, a drug approved to treat diabetes, aids weight loss by reducing appetite.

  • A similar drug called semaglutide was approved for obesity and became so popular that it caused shortages.

  • However, long-term insurance and access for patients is uncertain.

Another weight loss drug designed to treat diabetes is part of a promising class of new drugs that may aid weight loss.

Tirzepatide, sold under the brand name Mounjaro, has attracted attention for its dramatic weight loss results, including a clinical study that found patients lost 20% of their body weight in 16 months while taking it.

The study results are a groundbreaking level of weight loss typically unheard of without weight loss surgery, Dr. Robert Gabbay, chief scientific and medical officer of the American Diabetes Association, told USA Today.

Despite the potential, there are many unknowns about the future of the drug, including patient access, according to an expert in obesity medicine.

Here’s how tirzepatide works, how it’s prescribed, and potential downsides, including side effects, cost, and insurance issues.

It’s not yet approved for weight loss, but doctors can prescribe it

One of the most popular weight loss medications in existence, called semaglutide, originated as a diabetes drug and was approved by the FDA in 2021 for the treatment of obesity, becoming so popular that it caused shortages.

A similar story may play out with tirzepatide: While it’s not FDA-approved for weight loss, practitioners expect that to change, based on research showing its potential for obese patients.

“We expect it to be approved for the treatment of obesity,” endocrinologist and obesity medicine specialist Dr. Scott Isaacs to Insider, though it’s not clear how soon.

In the meantime, patients can still access the drug. The lack of FDA approval for weight loss means manufacturers can’t market the drug for weight loss, Isaacs said. Since tirzepatide is already FDA-approved for use in diabetes, doctors can prescribe it to patients, even for another purpose, if they think it will help.

It helps reduce appetite, similar to drugs such as semaglutide

Tirzapetide works similarly to other diabetes medications used to treat obesity, according to Isaacs.

“It’s more like than different than other drugs,” he said.

It acts on a hormone called GLP-1, which regulates appetite so that patients taking the drug feel fuller. Tirzapetide also interacts uniquely with another hormone related to insulin.

Some studies have claimed that tirzepatide is more effective for weight loss than other medications, based on a clinical trial showing increased weight loss.

But Isaacs said the evidence is inconclusive, as the study was designed to focus on diabetes, not weight loss, and did not use the strongest dose of semaglutide available.

“It’s considered more effective, but how much more nobody really knows,” he said.

Like similar medicines, tirzepatide can cause side effects such as nausea.

It can be difficult to pay in the long term

One of the biggest questions about tirzepatide right now is whether it will be affordable and accessible to patients who need it over time.

Typically, the high cost of weight loss medications can be a deterrent for patients. Semaglutide, for example, is listed at a price of $1,349 for a month’s supply for the treatment of obesity.

According to Isaacs, most insurance plans don’t cover weight loss medications, and those that do require a lot of paperwork.

“It’s a huge burden to prove that patients are eligible for the drug,” he said.

Tirzepatide gained popularity as a weight-loss prescription because of a rebate that made the drug available for $25 for a one- to three-month supply, according to the manufacturer’s website. Now that discount is only available to people with type 2 diabetes.

The catch with weight loss medications such as tirzepatide and semaglutide is that patients must continue to take the medication to maintain weight loss.

“We want to take the drugs long-term because we know that if they stop taking them, the weight will come back,” Isaacs said.

However, the discount expires next year, so patients taking tirzapetide will have to find another way to pay for the drug.

“There’s a lot of unknowns. We’re doing our best and there’s hope that things will change,” Isaacs said. “I am very open to patients, but I am worried about June next year.”

Read the original article on Insider

What you need to know about Mounjaro, the next breakthrough drug awaiting FDA approval to treat weight loss

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