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Accelerated drug tirzepatide for FDA weight loss indication: what to know about it

Tirzepatide, an injectable drug already approved by the Food and Drug Administration (FDA) to treat type 2 diabetes, is likely to receive FDA approval for another indication — weight loss — later this year, according to several reports.

Eli Lilly’s medication has the potential to become a “blockbuster” weight loss drug, according to reports. However, experts warn that many patients may not be able to afford it.

“Tirzepatide is currently approved by the FDA for the treatment of type 2 diabetes, but is being fast-tracked by the FDA to receive an indication for the treatment of obesity,” said Dr. Boston-based Fatima Stanford told Fox News Digital.

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Stanford is an expert in obesity medicine and an associate professor of medicine and pediatrics at Harvard Medical School.

She also works in the endocrine division at Massachusetts General Hospital.

A drug called tirzepatide has the potential to become a

A drug called tirzepatide has the potential to become a “blockbuster” weight loss drug, according to reports. However, experts warn that many patients may not be able to afford it.
(iStock)

Here’s a deeper look at some of the issues surrounding this drug and its potential.

What is the definition of obesity and overweight?

To diagnose obesity, many healthcare professionals use the Body Mass Index screening tool.

“If your BMI is 25.0 to <30, you are within the overweight range," according to the Centers for Disease Control and Prevention (CDC).

“If your BMI is 30.0 or higher, you fall into the obesity range.”

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Approximately 70% of American adults are obese or overweight, says the FDA.

These conditions are associated with several of the leading causes of death, including heart disease, stroke and diabetes.

How do current weight loss medications work?

The body normally releases two hormones, GLP-1 (glucagon-like peptide) and GIP (glucose-dependent insulinotropic polypeptide), to stimulate the pancreas to release insulin, according to reports.

A current class of weight loss drugs on the market has become trending on TikTok after users discovered celebrities like Elon Musk and Andy Cohen highlighting their success with them.

Feeling full sooner – also known as early satiety – leads people to eat less and potentially lose a lot of weight.

Feeling full sooner – also known as early satiety – leads people to eat less and potentially lose a lot of weight.
(iStock)

They are known as GLP-1 receptor agonists, which work by binding to receptors in the body to stimulate the pancreas to produce insulin. This mimics the effects of what the hormone GLP-1 does in the body, according to the University of Utah Health website.

Victoza, Ozempic and Trulicity are some of the brands that are GLP-1 receptor agonists and initially developed for the treatment of diabetes, the website added.

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When people start to eat, it stimulates the release of insulin for better blood sugar control.

Tirzepatide may be more effective because it binds to two receptors that decrease feelings of hunger – compared to just one receptor for current weight-loss drugs.

But while the drugs regulate blood sugar levels, the researchers found that the drugs also simultaneously cross receptors in the brain to signal people that they are full, according to the University of Utah Health website.

This feeling of fullness sooner – also known as early satiety – leads people to eat less and potentially lose a lot of weight.

How does tirzepatide work?

Tirzepatide “is a dual agonist, including a GLP-1 agonist and a GIP, that helps regulate blood sugar and weight,” said Dr. Stanford.

It may be more effective than current weight loss drugs because it binds to two receptors that decrease feelings of hunger, compared to just one receptor, as highlighted on social media platforms.

A young woman talks with her doctor.  The side-effect profile of tirzepatide, an Eli Lilly drug, was similar to other therapies approved to treat obesity that lowered blood sugar.  The most common adverse effects were related to the gastrointestinal tract, including nausea, vomiting, diarrhea and constipation.

A young woman talks with her doctor. The side-effect profile of tirzepatide, an Eli Lilly drug, was similar to other therapies approved to treat obesity that lowered blood sugar. The most common adverse effects were related to the gastrointestinal tract, including nausea, vomiting, diarrhea and constipation.
(iStock)

Tirzepatide is approved by the FDA under the brand name Mounjaro to improve blood sugar control for adults with type 2 diabetes, according to an FDA press release sent out last May.

The drug is given as an injection under the skin once a week.

Eli Lilly hoped to expand its use by conducting a double-blind randomized clinical trial known as SURMOUNT-1; sought to compare the efficacy and safety of tirzepatide with a placebo.

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“Participants taking tirzepatide lost up to 52 lb. (24 kg) in this 72-week phase 3 study,” the press release said last year.

Part of the reason more patients aren’t getting these obesity drugs is that their health insurance doesn’t cover these weight-loss drugs, a medical professional said.

Among participants taking the highest 15 mg dose, 63% of people achieved at least 20% body weight reduction as an important secondary endpoint, compared with 1.3% of those taking placebo.

More than half of the participants who took 10 mg also had at least a 20% reduction in body weight.

What are the side effects of tirzepatide?

The side effect profile of tirzepatide was similar to other therapies approved for the treatment of obesity that lowered blood sugar.

The most common adverse effects were related to the gastrointestinal tract, including nausea, vomiting, diarrhea and constipation.

Does health insurance cover tirzepatide?

“That will likely depend on the price if the drug is approved, so it’s hard to say without knowing the annual price,” said Sarah Emond, executive vice president and chief operating officer at the Institute for Clinical and Economic Review (ICER). non-profit, she told Fox News Digital.

Most insurers cover Victoza (liraglutide) and Ozempic (semaglutide) for the treatment of diabetes.

But only a few cover Saxenda (liraglutide) and Wegovy (semaglutide) for treating obesity, said Dr. Stanford of Boston.

“Insurers actually treat diabetes as a disease and cover [the costs of drugs for it]refusing to cover the same obesity drugs,” said a doctor in Boston.
(iStock)

The brands of the two drugs are different for treating obesity and diabetes, she emphasized, even though they are the same genetic drug for both indications.

“But insurers really treat diabetes as a disease and cover them, while refusing to cover the same drugs for obesity.”

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Only a few people who can benefit from medical treatments for obesity are receiving them, even though the drugs are considered safe and effective treatments, according to ICER’s recent report on obesity control.

Part of the reason more patients aren’t getting these types of obesity drugs, Emond said, is that health insurance doesn’t cover these weight-loss drugs.

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“In part, this lack of coverage is due to negative experience with previous generations of obesity drugs,” she said.

“However, given that obesity is a chronic disease with important long-term health consequences, it seems reasonable that new obesity therapies such as tirzepatide, if approved, [may] be covered not as an optional add-on determined by employers, but as a core element of health insurance.”

What could be a fair price for the drug?

ICER performs analyzes to calculate fair prices for new drugs, determining what price corresponds to the clinical benefit, noted Emond.

In its latest obesity management report, ICER looked at “Drug X”, which has a similar therapeutic profile to tirzepatide.

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“Based on the clinical data available at the time on patient benefit, a ‘fair’ price for tirzepatide could be around $13,000 annually,” noted Emond.

“If approved, we’re not sure what it might actually cost out of pocket for patients,” she also said.

“This will depend on several factors, including the price chosen by the manufacturer, as well as benefit design and form placement decisions by payers and employers.”

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