FDA approves Eli Lilly drug tirzepatide for weight loss

The Food and Drug Administration approved it Wednesday. Eli Lillyblockbuster drug Tirzepatide for weight losspaving the way for even broader access to the treatment in the United States

The drug’s active ingredient, tirzepatide, is already approved for the treatment of type 2 diabetes under the name Mounjaro from May 2022.

But new FDA approval means overweight adults who are obese or have at least one weight-related disease can use the drug, sold as Zepbound, for chronic weight management.

According to some information, Zepbound will be available in the US by the end of the year, with a list price of around $1,060 for one month. release From Eli Lilly.

Before Wednesday’s approval, many patients were using tirzepatide off-label for weight loss, further fueling the frenzy of demand for a treatment that can help patients lose weight. novo nordiskWegovy and Ozempic. All three drugs have faced supply constraints for months due to surging demand.

Weight loss The approval further positions Eli Lilly as a strong competitor to Novo Nordisk in the emerging obesity drug market, which Wall Street analysts say has the potential to grow globally. I think it’s sexual. 100 billion dollar industry The rise in drug use has raised questions about how the changes will affect various industries, but it may be too early to predict how many people will use drugs. .

This approval was also based on the fact that obesity affects estimated body weight. 650 million adults globally and broadly 40% of adult population in the united states

“Obesity and overweight are serious conditions that can be associated with leading causes of death, including heart disease, stroke, and diabetes,” said John John, director of the FDA’s Division of Diabetes, Dyslipidemia, and Obesity. Dr. Sharetz said. Center for Drug Evaluation and Research “Given the increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need.”

Zepbound is a once-weekly injection that requires dose escalation over 4 to 20 weeks to achieve a target dose size of 5, 10, or 15 milligrams per week.

This drug works by activating two hormones that are naturally produced in the body: glucagon-like peptide 1, known as GLP-1, and glucose-dependent insulinotropic polypeptide (GIP).

This combination is said to slow stomach emptying, make you feel full longer, and suppress appetite by slowing hunger signals in the brain.

The FDA said the approval was based on Eli Lilly’s two late-stage studies of tirzepatide that evaluated its effects on weight loss after 72 weeks.

In a late-stage study of more than 2,500 obese adults without diabetes, adults who took 5 milligrams of tirzepatide for 72 weeks lost about 16 percent of their body weight on average. Further weight loss was seen with increasing doses of the drug, with the 15-milligram dose leading to an average weight loss of 22.5%.

another Late study found that tirzepatide reduced body weight by up to 15.7% in people who were obese or overweight and had type 2 diabetes.

Still, access to tirzepatide and other diabetes and obesity treatments remains a major challenge.

The list price for tirzepatide for weight loss is $1,059.87 per month for six different dose sizes, approximately 20% less than Wegovy’s price, Eli Lilly said in a press release. The company noted that patients will likely pay less out-of-pocket if they have insurance.

Eli Lilly also said it would launch a commercial savings card program to expand access to Zepbound, allowing insureds for the drug to pay as little as $25 for a one-month or three-month prescription. payment may become possible. On the other hand, those whose insurance doesn’t cover their Zepbound could pay as little as $550 for their prescription.

“Broad access to these medicines is important, which is why Lilly is committed to working with our healthcare, government, and industry partners to ensure that those who could benefit from Zepbound have access to them. ,” said Mike Mason, executive vice president and president of Eli Lilly Diabetes. And he also talked about obesity in his statement.

An even bigger problem is that many insurance companies are dropping weight loss drugs from their plans. Those insurers cite the steep costs of covering these drugs, and some say they want to see more data proving the drugs’ health benefits 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 attack and stroke by 20%. The results suggest that Wegovy and similar drugs like Mounjaro may have long-term heart health benefits.

It’s unclear whether Zepbound will eventually face supply issues following widespread Munjaro shortages in the United States.

On Wednesday, Eli Lilly CEO David Ricks told reporters that the company is ready to launch Zepbound in earnest and has the supplies to do so. He also noted that all doses of Munjaro are currently listed as available on the FDA’s drug shortage website.

Rix added that the company is working to increase production capacity for tirzepatide.

“We are ready to launch a big, bold undertaking as we move toward the end of the year, and we will work hard to continue expanding our capacity to meet the needs of our bariatric patients,” Ricks told reporters. Ta.

According to the FDA’s approval, Zepbound, like other weight loss drugs, comes with side effects such as nausea, diarrhea, vomiting, constipation, abdominal discomfort or pain, fatigue, and allergic reactions. label.

The agency also noted that Zepbound causes thyroid C-cell tumors in rats, but it is unclear whether the drug has such an effect in humans.

The FDA says Zepbound should not be used in patients with a personal or family history of medullary thyroid cancer (cancer that forms inside the thyroid gland) or a rare disease called multiple endocrine tumor syndrome type 2. We recommend that you do so.

The agency also said Zepbound should not be used in combination with Mounjaro or other weight-loss or diabetes drugs that target GLP-1 because the “safety and efficacy of the combination” has not been established.

Other warnings from authorities regarding Zepbound include pancreatic inflammation, gallbladder problems, acute kidney injury, and suicidal behavior or thoughts.

“Historically, anti-obesity drugs have been associated with suicidal thoughts, which is something to really be aware of when using weight loss treatment,” said Dr. Leonard Glass, Eli Lilly’s senior vice president of global medical affairs. Ta. Diabetes and Obesity spoke on the phone with reporters. “So we encourage people to be aware of this and go to their health care provider for side effects. Side effects can be monitored.”