Tirzepatide drug fast-tracked for weight loss indication by FDA: What to know about it
Tirzepatide, an injection medication 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 multiple reports.
The medication from Eli Lilly has the potential to become a “blockbuster” weight-loss drug, according to reports. Yet experts caution that many patients may not be able to afford it.
“Tirzepatide is currently FDA-approved for treating Type 2 diabetes, but it is being fast-tracked through the FDA to receive an indication for the treatment of obesity,” Dr. Fatima Stanford of Boston told Fox News Digital.
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Stanford is an obesity medicine specialist and an associate professor of medicine and pediatrics at Harvard Medical School.
She also works in the endocrine division at Massachusetts General Hospital.
Here’s a deeper look at some of the issues around this drug and its potential.
What’s the definition of obesity and overweight?
To diagnose obesity, many health care providers use the Body Mass Index screening tool.
“If your BMI is 25.0 to <30, it falls within the overweight range,” according to the Centers for Disease Control and Prevention (CDC).
“If your BMI is 30.0 or higher, it falls within the obesity range.”
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Approximately 70% of American adults have obesity or are overweight, the FDA says.
These conditions are associated with several 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 medications on the market have been trending on TikTok after users discovered celebrities like Elon Musk and Andy Cohen highlighting their success with them.
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’s website.
Victoza, Ozempic and Trulicity are some of the brand names that are GLP-1 receptor agonists and initially developed for the treatment of diabetes, the website added.
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When people start eating, that stimulates the release of insulin for better blood sugar control.
Tirzepatide may be more effective because it binds to two receptors that decrease the sense of hunger — compared to only one receptor for current weight-loss medications.
But while the drugs regulate blood sugar levels, researchers found that the drugs also simultaneously cross the receptors in the brain to signal to people that they’re full, per the University of Utah Health’s website.
This feeling of being full sooner — also known as early satiety — leads people to eat less and potentially to lose a lot of weight.
How does tirzepatide work?
Tirzepatide “is a dual agonist, including a GLP-1 agonist and a GIP, which helps regulate blood sugar and weight,” Dr. Stanford said.
It may be more effective than current weight-loss medications because it binds to two receptors that decrease the sense of hunger, compared to only one receptor, such as those highlighted on social media platforms.
Tirzepatide is FDA-approved under the brand name Mounjaro to improve blood sugar control for adults with Type 2 diabetes, according to an FDA press release sent out this past May.
The drug is administered as an injection under the skin once a week.
Eli Lilly hoped to expand its use by performing a double-blind randomized clinical trial known as SURMOUNT-1; it sought to compare the effectiveness and safety of tirzepatide to 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 are not receiving these obesity medications is that their health insurance is not covering these drugs for weight loss, said one medical professional.
Among the participants who took the highest dose of 15mg, 63% of the people achieved at least 20% body-weight reductions as a key secondary endpoint, compared to 1.3% of those taking a placebo.
Over half the participants who took 10 mg also had at least 20% body-weight reduction.
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 reduced blood sugars.
The most common adverse effects were gastrointestinal-related, including nausea, vomiting, diarrhea and constipation.
Will health insurance cover tirzepatide?
“This will likely depend on the pricing if the drug is approved, so it’s hard to say without knowing the annual price,” Sarah Emond, executive vice president and chief operating officer for the Institute for Clinical and Economic Review (ICER), a Boston-based nonprofit, told Fox News Digital.
Most insurer companies cover Victoza (liraglutide) and Ozempic (semaglutide) for the treatment of diabetes.
But only a few cover Saxenda (liraglutide) and Wegovy (semaglutide) for the treatment for obesity, Dr. Stanford of Boston said.
The brand names of both drugs are different for the treatment for obesity versus diabetes, she emphasized, even though they are 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 may benefit from medical treatments for obesity are receiving them, though the drugs are considered safe and effective treatments, according to ICER’s recent report on obesity management.
Part of the reason more patients are not receiving these type of obesity medications, said Emond, is that their health insurance is not covering these drugs for weight loss.
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“In part, this lack of coverage is due to the negative experience with earlier generations of obesity medications,” she said.
“However, given that obesity is a chronic disease with important long-term health consequences, it seems reasonable that newer therapies for obesity 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 conducts analyses to calculate fair prices for new drugs by determining what price matches the clinical benefit, Emond noted.
In their latest obesity management report, ICER examined “Drug X,” which has a similar therapeutic profile to tirzepatide.
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“Based on the clinical data available at that time about the patient benefit, a ‘fair’ price for tirzepatide could be around $13,000 annually,” Emond noted.
“If approved, we’re not sure what it might actually cost patients out-of-pocket,” she also said.
“That will depend on multiple factors, including the price chosen by the manufacturer, as well as benefit design and formulary placement decisions by payers and employers.”