FDA Approves Blockbuster Weight Loss Drug

(The Hill) The Food and Drug Administration (FDA) approved Eli Lilly’s blockbuster diabetes drug for weight loss management on Wednesday, giving patients another tool and opening the door to potentially using much wider.

Formal FDA approval means tirzepatide could be covered by most insurance plans, making it more affordable for millions of patients and likely increasing massive demand for weight-loss drugs like Wegovy and Ozempic.

The agency approved Novo Nordisks Ozempic for diabetes and Wegovy for obesity in 2017 and 2021, respectively. Both drugs use the active ingredient semaglutide, but Wegovy was to date the only drug approved on the market solely for obesity.

Tirzepatide had already been approved to treat type 2 diabetes under the name Mounjaro. The drug will be marketed as Zepbound for chronic weight management in obese or overweight adults with at least one weight-related disease.

Zepbound is a weekly injection that works by activating two hormones produced naturally in the body to reduce appetite and food consumption.

The drug is already widely prescribed off-label for weight loss in obese patients, but insurance companies may not cover it.

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 John Sharretts, director of the Division of Diabetes, Disorders Lipid and Obesity of the FDA, in a press release. In light of increasing rates of obesity and overweight in the United States, today’s approval addresses an unmet medical need.

Zepbound is expected to be available in the United States by the end of the year in six doses at a list price of $1,059.87 per month, Lilly said. It’s a direct competitor to Wegovy, which costs around $1,300 per month.

The list price does not reflect the typical cost paid by patients, and the company said it is establishing a commercial savings card program. When a drug’s list price is higher, manufacturers may offer a larger discount to pharmacy benefit managers, who are expected to pass the savings on to patients.

In addition to their cost, weight loss drugs face other accessibility problems. Private insurers are unwilling to cover Wegovy and its sister drug Ozempic because they are considered lifestyle or cosmetic drugs and are not essential. Ozempic is only approved as a treatment for diabetes, although it is prescribed off-label as an anti-obesity drug. Federal law prohibits Medicare from covering weight-loss drugs.

“Far too many barriers continue to prevent obese people from accessing obesity treatments that could lead to significant weight loss,” said Mike Mason, executive vice president and president of Lilly Diabetes and Obesity. , in a press release. “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 .

In a large clinical trial, non-diabetic patients lost an average of 18 percent of their body weight compared to those on placebo when used in combination with a low-calorie diet and increased physical activity.

About 70 percent of American adults suffer from obesity or are overweight, and many of them suffer from a weight-related illness. Losing 5 to 10 percent of body weight through diet and exercise has been linked to a reduced risk of cardiovascular disease in obese or overweight adults, the FDA said.