Eli Lilly and Company, pharmaceutical company headquarters in Alcobendas, Madrid, Spain.
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The active ingredient of the drug, tirzepatide, has already been approved for the treatment of type 2 diabetes under the name Mounjaro since May 2022.
But the new FDA approval means that obese or overweight adults with at least one weight-related condition can use the drug, which will be marketed as Zepbound, for chronic weight management.
Zepbound is expected to be available in the United States by the end of the year and will cost around $1,060 for a month’s supply, according to a release by Eli Lilly.
Before Wednesday’s approval, many patients had used tirzepatide off-label for weight loss, adding to a frenzy of demand for treatments that can help patients lose weight, such as Novo NordiskIt’s Wegovy and Ozempic. All three drugs have faced supply constraints for months due to high demand.
Weight loss The approval further makes Eli Lilly a formidable competitor to Novo Nordisk in the burgeoning obesity drug market, which Wall Street analysts say could become a A $100 billion industry by 2030. Increased drug use raises questions about how the changes will affect a wide range of industries – although it may be too early to tell how many people will use them.
“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,” said Dr. John Sharretts, director of the division of diabetes, lipid disorders and obesity to the FDA. Center for Drug Evaluation and Research. “In light of the increasing rates of obesity and overweight in the United States, today’s approval addresses an unmet medical need. »
Zepbound is an injection given once a week, and the dosage should be increased over four to 20 weeks to reach target doses of 5, 10, or 15 milligrams per week.
The drug works by activating two hormones produced naturally in the body: glucagon-like peptide-1, known as GLP-1, and glucose-dependent insulinotropic polypeptide, or GIP.
This combination is said to slow stomach emptying, making people feel full longer and suppressing appetite by slowing hunger signals in the brain.
The FDA said the approval was based on two of Eli Lilly’s late-stage trials of tirzepatide, which evaluated its effects on weight loss after 72 weeks.
In a late-stage study of more than 2,500 adults who were obese but not diabetic, those who took 5 milligrams of tirzepatide for 72 weeks lost about 16% of their body weight on average. Higher doses of the drug were associated with even greater weight loss, with a dose of 15 milligrams resulting in 22.5% weight loss on average.
Another late-stage study found that tirzepatide caused weight loss of up to 15.7% in people who were obese or overweight and had type 2 diabetes.
Yet access to tirzepatide and other treatments for diabetes and obesity remains a major challenge.
The list price of tirzepatide for weight loss is $1,059.87 per month for six different doses, about 20 percent less than Wegovy, Eli Lilly said in a news release. The company noted that the amount a patient will pay out of pocket will likely be lower if they have insurance.
Eli Lilly also announced the launch of a commercial savings card program to expand access to Zepbound, which could allow people with insurance coverage for the drug to pay as little as $25 for a prescription of one or three months. Meanwhile, those whose insurance doesn’t cover Zepbound might be able to pay as little as $550 for these prescriptions.
“Broader access to these medicines is essential, which is why Lilly is committed to working with healthcare, government and industry partners to ensure that people who could benefit from Zepbound can access them said Mike Mason, executive vice president and president of Eli Lilly Diabetes. and obesity, in a press release.
The biggest problem is that many insurance companies are removing weight loss medications from their plans. These insurers cite the extreme costs of covering these drugs, and some say they want to see more data demonstrating the health benefits of these drugs, beyond weight loss.
Preliminary data is already available: a recent late-stage trial found that Novo Nordisk’s weight-loss drug Wegovy reduced the risk of cardiovascular events such as heart attacks and strokes by 20%. The results suggest that Wegovy and similar drugs like Mounjaro may have long-term beneficial effects on heart health.
It’s unclear whether Zepbound will eventually run into supply issues after the U.S. experienced widespread shortages of Mounjaro.
On Wednesday, Eli Lilly CEO David Ricks told reporters that the company was ready to fully launch Zepbound and had the resources to do so. He also noted that all doses of Mounjaro are now listed as available on the FDA’s drug shortage website.
The company is working to increase its tirzepatide production capacity, Ricks added.
“We are ready for a big, bold launch here towards the end of the year and we will work hard to continue to expand our supply capacity to meet the needs of obese people,” Ricks told reporters.
Similar to other weight loss medications, Zepbound is associated with side effects such as nausea, diarrhea, vomiting, constipation, abdominal discomfort and pain, fatigue, and allergic reactions, among others, according to FDA approval. label.
The agency also noted that Zepbound causes thyroid C-cell tumors in rats, but it is unclear whether the drug has this effect in humans.
The FDA recommends against the use of Zepbound in patients with a personal or family history of medullary thyroid cancer – cancer that forms inside your thyroid gland – or in people with a rare condition called medullary thyroid cancer. multiple endocrine neoplasia type 2.
The agency also said that Zepbound should not be used in combination with Mounjaro or another weight loss or diabetes drug targeting GLP-1 because “the safety and effectiveness of coadministration” are not known. have not been established.
The agency’s other warnings about Zepbound include inflammation of the pancreas, gallbladder problems, acute kidney injury, and suicidal behavior or thoughts.
“In the past, anti-obesity medications have been associated with suicidal ideation, and that’s definitely something to watch for when you’re treating someone for weight loss,” said Dr. Leonard Glass, vice -Eli Lilly’s senior president of global medical affairs for diabetes and obesity, said on a call with reporters. “Therefore, we encourage people to keep an eye on this and consult their health care provider for any side effects, they can be monitored.”