Tirzepatide drug accelerated for weight loss indication by FDA: what you need to know about it

Tirzepatide, an injection 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 drug has the potential to become a “blockbuster” weight-loss drug, according to reports. Still, experts warn that many patients may not be able to afford it.

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

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

She also works in the endocrine division of 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. Still, experts warn that many patients may not be able to afford it.
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Here is a closer look at some of the issues with this drug and its potential.

What is the definition of obesity and overweight?

To diagnose obesity, many healthcare providers use the body mass index screening tool.

“If your BMI is between 25.0 and <30, it's in the overweight range," according to the Centers for Disease Control and Prevention (CDC).

“If your BMI is 30.0 or higher, it’s in the obese range.”

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According to the FDA, approximately 70% of American adults are obese or overweight.

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

How do current weight loss drugs 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 are trending on TikTok after users discovered celebrities like Elon Musk and Andy Cohen highlighting their success with them.

The feeling of being full sooner – also known as early satiety – causes people to eat less and potentially lose a lot of weight.

The feeling of being full sooner – also known as early satiety – causes people to eat less and potentially lose a lot of weight.
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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 GLP-1 hormone does in the body, according to the University of Utah Health website.

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

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When people start eating, 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, 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 website. Health.

This feeling of being full sooner – also known as early satiety – causes 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,” Dr. Stanford said.

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

A young woman discusses with her doctor.  The side effect profile of Eli Lilly's drug tirzepatide was similar to other therapies approved for the treatment of obesity that lower blood sugar.  The most common side effects were gastrointestinal, including nausea, vomiting, diarrhea and constipation.

A young woman discusses with her doctor. The side effect profile of Eli Lilly’s drug tirzepatide was similar to other therapies approved for the treatment of obesity that lower blood sugar. The most common side effects were gastrointestinal, including nausea, vomiting, diarrhea and constipation.
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Tirzepatide is FDA-approved under the brand name Mounjaro to improve blood sugar control in adults with type 2 diabetes, according to an FDA press release sent last May.

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

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

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“Participants taking tirzepatide lost up to 52 pounds (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 because their health insurance doesn’t cover these drugs for weight loss, a medical professional has said.

Among participants who took the highest dose of 15 mg, 63% of people achieved a reduction in body weight of at least 20% as a key secondary endpoint, compared to 1.3% of those who took a placebo.

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

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 lower blood sugar.

The most common side effects were gastrointestinal, including nausea, vomiting, diarrhea and constipation.

Will health insurance cover tirzepatide?

“It 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 of the Institute for Clinical and Economic Review ( ICER), a Boston facility. nonprofit, 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 the treatment of obesity, said Dr. Stanford of Boston.

“Insurers actually treat diabetes as a disease and cover [the costs of drugs for it]while refusing to cover the same obesity drugs,” said a Boston doctor.
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The brand names of the two drugs are different for the treatment of obesity versus diabetes, she pointed out, even though it is the same genetic drug for both indications.

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

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Only some people who could benefit from medical treatments for obesity receive them, although drugs are considered safe and effective treatments, according to ICER’s recent report on obesity management.

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

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

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

What could be a fair price for the drug?

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

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

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

“If approved, we don’t know what it could actually cost 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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