Eli Lilly and Company, pharmaceutical company headquarters in Alcobendas, Madrid, Spain.
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The drug’s active ingredient, tirzepatide, is already approved for the treatment of type 2 diabetes under the name Mounjaro from May 2022.
However, the new FDA approval means that adults who are obese or overweight with at least one weight-related condition can use the drug, which will be marketed as Zepbound, for chronic weight management.
Zepbound will be available in the US by the end of the year and will have a list price of about $1,060 for a month’s supply, according to release by Eli Lilly.
Before Wednesday’s approval, many patients had used tirzepatide off-label for weight loss, increasing demand for treatments that can help patients lose weight, such as Novo Nordisk‘s Wegovy and Ozempic. All three drugs have faced supply constraints for months due to rising demand.
The weight loss The approval further establishes Eli Lilly as a formidable competitor to Novo Nordisk in the nascent market for anti-obesity drugs, which Wall Street analysts believe could grow to A $100 billion industry by 2030. Increased drug use has raised questions about how the changes will affect a 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, including heart disease, stroke and diabetes,” said Dr John Sharretts, director of diabetes, lipid disorders and obesity at FDA. Center for Drug Evaluation and Research. “In light of rising rates of obesity and overweight in the United States, today’s approval addresses an unmet medical need.”
Zepbound is an injection that is given once a week, and the dose must be increased over four to 20 weeks to reach the target dose sizes of 5, 10, or 15 milligrams per week.
The drug works by activating two naturally produced hormones in the body: glucagon-like peptide-1, known as GLP-1, and glucose-dependent insulinotropic polypeptide, or GIP.
The combination is said to slow stomach emptying, making people feel fuller for longer, and to suppress appetite by slowing hunger signals to 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 with obesity but not diabetes, those who received 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 15-milligram dose leading to an average weight loss of 22.5%.
Other final stage study found that tirzepatide caused up to 15.7% weight loss in people who are obese or overweight and have type 2 diabetes.
However, 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 a month for six different dose sizes, which is about 20% lower than Wegovy’s, Eli Lilly said in a news release. The company noted that the amount a patient pays out of pocket will likely be less if they have insurance.
Eli Lilly also said it is launching 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 monthly or quarterly prescription. Meanwhile, those whose insurance doesn’t cover Zepbound may be able to pay up to $550 for those prescriptions.
“Wider access to these medicines is critical, which is why Lilly is committed to working with health, government and industry partners to ensure that people who can benefit from Zepbound can access it.” , said Mike Mason, executive vice president and president of Eli Lilly Diabetes. and Obesity, in their statement.
The biggest issue is that many insurance companies reject weight loss drugs from their plans. Those insurers cite the extreme cost of covering these drugs, and some say they want to see more data demonstrating the drugs’ health benefits beyond weight loss.
The preliminary data is already in: A recent late-stage trial found that Novo Nordisk’s weight loss drug Wegovy reduced the risk of cardiovascular events such as heart attack and stroke by 20 percent. The results suggest that Wegovy and similar drugs such as Mounjaro could have long-term benefits for heart health.
It’s unclear if Zepbound will eventually face supply issues after the US saw widespread Mounjaro shortages.
On Wednesday, Eli Lilly CEO David Ricks told reporters that the company is ready to fully launch Zepbound and has the supply 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 ramp up production capacity for tirzepatide, Ricks added.
“We are prepared for a big bold launch here towards the end of the year and will work hard to continue to expand our supply capacity to meet the needs of people with obesity,” Ricks told reporters.
Similar to other weight loss drugs, 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. inscription.
The agency also noted that Zepbound caused thyroid C-cell tumors in rats, but it is unclear whether the drug has this effect in humans.
The FDA advises against using 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 multiple endocrine neoplasia syndrome type 2.
The agency also said Zepbound should not be used in combination with Mounjaro or another weight loss or diabetes drug that targets GLP-1 because “the safety and efficacy of coadministration” 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 thinking.
“Anti-obesity drugs in the past have been associated with suicidal ideation, and that’s really something to be aware of when you’re treating someone for weight loss,” said Dr. diabetes and obesity, he said during a conversation with reporters. “So we encourage people to monitor this and go to their healthcare provider for any side effects, they can be monitored.”