After the raging success of weight loss drugs Wegovy, Ozempic and more, Eli Lilly has had its request to market its tirzepatide medication for weight loss approved by the U.S. Food and Drug Administration.
Tirzepatide, which is branded as Mounjaro for diabetes, has been in use as an “off-label” medication for weight loss, but now the FDA approval will allow it to be sold as a weight loss drug branded Zepbound.
The drugmaker shared in a press release that Zepbound will be available to patients in the U.S. by the end of this year.
Joe Nadglowski, the CEO of the Obesity Action Coalition, shared more on the new medication, which will be administered with an injection pen and sold at a cheaper list price than its main competitor, Ozempic.
“New treatment options bring hope to the many people with obesity who struggle with this disease and are seeking better options for weight management,” Nadglowski said in Eli Lilly’s release.
So, how does it work?
Good RX reported that "both Mounjaro and Wegovy work by mimicking gut hormones called incretins. Incretins signal the pancreas to release insulin after eating and tell the liver to make less glucose (sugar). They also slow the passage of food through the digestive tract and act on areas of the brain responsible for regulating your appetite."
The FDA’s director of its Division of Diabetes, Lipid Disorders, and Obesity, Dr. John Sharretts, says that the medication comes as obesity continues to rise.
“In light of increasing rates of both obesity and (being) overweight in the United States, today’s approval addresses an unmet medical need,” Sharretts said.
The approval from the agency came after Eli Lilly ran a study that found adults without diabetes, who averaged 231 pounds at the start of the trial and were given the highest approved dose of Zepbound, ended up losing 18% of their body weight compared to the placebo group.
However, while Zepbound and Ozempic may produce results, questions have come forward about the side effects of the medications, which include nausea, diarrhea, vomiting, constipation, and hair loss.
Other reports about Ozempic surfaced early last month, suggesting the possibility of mental health side effects stemming from the medication.
Still, with obesity, there also comes risks, and Sharretts says the FDA approval will offer some help to the growing crisis.
“Obesity and overweight are serious conditions that can be associated with some of the leading causes of death such as heart disease, stroke, and diabetes,” Sharretts said.