New single-dose vials of Zepbound weight loss drug available in the US

CNN
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Initial doses of weight loss drug Zepbound are now available in single-dose vials, drugmaker Eli Lilly announced Tuesday, a move the company says will “significantly” expand supply as it believes demand continues to be high.

Instead of a pre-filled pen, patients will use a syringe to draw the medicine.

Tirzepatide, the active ingredient in Zepbound and Mounjaro, is part of a new class of drugs used to treat obesity and diabetes that have skyrocketed in popularity, causing shortages — and prompting some people to use versions made by compounding pharmacies.

“These new vials not only help us meet the high demand for our obesity medications, but also expand access for patients looking for a safe and effective treatment option,” said Patrik Jonsson, president of Lilly Cardiometabolic Health and Lilly USA, in – a statement.

The new vials will be available exclusively to people who pay out-of-pocket through LillyDirect, the company’s platform that helps coordinate telehealth services and fill prescriptions for patients.

A four-week supply of 2.5-milligram (mg) vials is $399, and a four-week supply of 5-mg vials is $529, less than half the list price of other GLP-1 drugs for obesity, according to Eli Lilly.

Those prices are consistent with those offered through Lilly’s savings program for the uninsured, the company said. But the option to pay out of pocket for the vials now extends access to patients who are not eligible for the savings program, such as those on Medicare.

“Despite obesity being recognized as a serious chronic disease with long-term consequences, it is often misclassified as a lifestyle choice, leading to many employers and the federal government excluding drugs like Zepbound from coverage of insurance,” Jonsson said. “Outdated policies and lack of coverage for obesity drugs create an urgent need for more innovative solutions. Bringing Zepbound single-dose pills to patients will help more people living with obesity manage this chronic condition. We will also continue to push for a system that better aligns with science.”

Tirzepatide works by mimicking hormones that stimulate the release of insulin, increase satiety and reduce appetite. It targets two hormone receptors, GIP and GLP-1. Semgalutide, known as Ozempic for diabetes and Wegovy for weight loss, is also part of this broad class of drugs.

The continued shortage of tirzepatide and other popular weight-loss drugs has allowed combination versions of the treatments — with similar or related ingredients — to hit the market with less oversight and regulation from the US Food and Drug Administration.

The FDA issued a warning last month about compounded versions of semaglutide; The agency says it has received reports of adverse events — some requiring hospitalization — due to dosing errors related to units of measure, varying product concentrations and the use of multiple-dose vials. Patients “should not use a combination drug if an approved drug is available,” the agency said.

Eli Lilly has also raised concerns about the potential risks that combination versions of its drugs pose to patients. In an open letter in June, the company pointed out that it is “the only legal supplier of FDA-approved tirzepatide drugs” and that products from other unverified sources may be “false, counterfeit or otherwise unsafe.”

“(Safety) is our number one priority, and this is a great way for patients to know they’re getting genuine Lilly drugs,” said Rhonda Pacheco, group vice president for Lilly US Cardiometabolic Health. Thousands of people use LillyDirect every week, she said.

The experience for people who self-inject tirzepatide with a syringe that has been filled from a vial would likely be similar to using a prefilled pen — and may have some additional benefits, said Dr. Jody Dushay, an endocrinologist at Beth Israel Deaconess Medical Center and Assistant Professor of Medicine at Harvard Medical School.

“It’s old school, but I have patients with type 1 and type 2 diabetes who prefer the vial and syringe of pen devices. I don’t think it’s much of a big deal to use an insulin syringe versus an auto-injector unless someone has severe needle phobia,” she wrote in an email. “It’s not that difficult to make a syringe, although the elderly, those with limited dexterity and those with poor eyesight will be better off with the auto-injector.”

The syringe and vial could actually allow for some additional flexibility in dosages, especially for initial levels, Dushay said. Patients could draw less than 2.5 mg if they have severe side effects, or less than 5 mg if they are ready to increase, but not quite double the dose.

Also, most compounded versions of tirzepatide come in vials, so patients should be extra careful with the source of their medicine, she noted.

Data from clinical trials found that people using 5 mg tirzepatide injections lost about 15% of their weight after more than a year of treatment, on average.

Another recent study found that people using tirzepatide injections lost more weight and were more likely to reach specific weight loss goals than those on semaglutide.