Lilly launches cheaper weight loss drug Zepbound without injection pen

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

Instead of a prefilled injection pen, patients use a syringe to draw up the medicine.

Tirzepatide, the active ingredient in Zepbound and Mounjaro, belongs to a new class of drugs used to treat obesity and diabetes that have soared in popularity, leading to shortages — and prompting some people to resort to pharmacy-made versions.

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

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

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

Those prices are consistent with what Lilly's savings program offers to the uninsured, the company said, but the ability to pay for the vials out of pocket now expands access for patients who aren't eligible for the savings program, such as those with Medicare.

“Although obesity is recognized as a serious chronic disease with long-term consequences, it is often incorrectly classified as a lifestyle choice, leading many employers and the federal government to exclude medications like Zepbound from insurance coverage,” Jonsson said. “Outdated policies and lack of insurance coverage for obesity medications create an urgent need for more innovative solutions. Making single-dose vials of Zepbound available to patients will help more people with obesity manage this chronic disease. We will continue to advocate for a system that is more consistent with the science.”

Tirzepatide works by mimicking hormones that stimulate insulin secretion, 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, also belongs to this broad class of drugs.

Due to ongoing shortages of tirzepatide and other common weight loss medications, ready-made preparations of these drugs – with similar or related ingredients – have now come onto the market that are less strictly monitored and regulated by the U.S. 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, different product concentrations and the use of multidose vials. Patients “should not use a compounded drug if an approved drug is available,” the agency said.

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

“[Safety] is our top priority, and this is a great way for patients to know they are getting genuine Lilly medicines,” said Rhonda Pacheco, group vice president for Lilly US Cardiometabolic Health. Thousands of people use LillyDirect every week, she said.

For people who self-inject tirzepatide using a syringe filled from a vial, the experience would likely be similar to using a prefilled pen — and it may have some additional benefits, says Dr. Jody Dushay, an endocrinologist at Beth Israel Deaconess Medical Center and assistant professor of medicine at Harvard Medical School.

“It's old-fashioned, but I have patients with type 1 and 2 diabetes who prefer vials and syringes to pens. I don't think it's much worse to use an insulin syringe instead of an auto-injector unless someone has a severe needle phobia,” she wrote in an email. “It's not that difficult to draw up a syringe, although the elderly, people with limited dexterity, and people with poor eyesight are better off with the auto-injector.”

The syringe and vial might actually allow for a little more flexibility in dosing, especially in the starting dose, Dushay said. Patients could draw up less than 2.5 mg if they're having severe side effects, or less than 5 mg if they're willing to increase the dose but not quite double it.

In addition, most finished preparations of tirzepatide are available in ampoules, which is why patients should be especially careful about the origin of their medication, she noted.

Data from clinical trials have shown that people who received 5 mg injections of tirzepatide lost an average of about 15% of their weight after over a year of treatment.

Another recent study found that people who received tirzepatide injections lost more weight and were more likely to achieve certain weight loss goals than people who received semaglutide.