FDA approves Eli Lilly’s new weight loss drug Zepbound, cheaper than Wegovy

The market for government-approved medication targeting long-term weight reduction and maintenance is expanding. On Wednesday, the U.S. Food and Drug Administration approved Zepbound, which is made by Eli Lilly and Company and intended for use by adults with obesity or those suffering from a weight-related condition such as high blood pressure, type 2 diabetes or high cholesterol. The medication, which is intended to be combined with a reduced-calorie diet and increased physical activity, is expected to available by the end of the year.

Tirzepatide, the active ingredient in Zepbound for weight loss, is already approved under the trade name Mounjaro for use along with diet and exercise to help improve glucose levels in adults with type 2 diabetes mellitus.

“Obesity is a chronic disease that can result in serious health complications, including heart disease, stroke, and diabetes. Despite our knowledge of obesity as a treatable, chronic disease, people living with obesity still face many challenges in their health and weight management journey,” Joe Nadglowski, president and chief executive officer of the Obesity Action Coalition, said in a statement issued by Lilly. “New treatment options bring hope to the many people with obesity who struggle with this disease and are seeking better options for weight management.”

“In light of increasing rates of both obesity and overweight in the United States, today’s approval addressed an unmet medical need,” added John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research.

Approximately 70% of American adults are obese or overweight, according to the FDA, and losing 5% to 10% of body weight through diet and exercise has been associated with a reduced risk of cardiovascular disease in adults with obesity or overweight.

How Zepbound works

Zepbound activates receptors of hormones secreted from the intestine and glucose-dependent insulinotropic polypeptide (GIP) to reduce appetite and food intake, FDA officials noted. It is administered by injection under the skin once weekly, and the dosage must be increased over four to 20 weeks to achieve the target dosages of 5 milligram (mg), 10 mg or 15 mg once weekly. The maximum dosage of Zepbound is 15 mg once weekly.

According to the maker of Zepbound, people who are commercially insured with coverage for the drug may be eligible to pay as little as $25 for a one-month or three-month prescription. Those who are commercially insured without coverage for Zepbound may be eligible to pay a minimum of $550 for a one-month prescription of Zepbound, which Lilly says is approximately 50% lower than the list price of $1,059.

As BioPharmaDive.com reports, that is about 20% less than the list price of rival drug Wegovy, made by Novo Nordisk. (Wegovy and Ozempic are the same drug, with different prices before insurance; Ozempic costs $936 per month, according to CNN.com, and Wegovy costs $1,349 per month.)

Related: The race is on: Some drugmakers falling behind in developing new weight loss pills

The FDA said Zepbound’s effectiveness was established in two randomized, double-blind, placebo-controlled trials of adults with obesity or overweight with at least one weight-related condition. These studies measured weight reduction after 72 weeks in a total of 2,519 patients (who received either 5 mg, 10 mg, or 15 mg of Zepbound once weekly) and a total of 958 patients (who received once-weekly placebo injections). In both trials, after 72 weeks of treatment, patients who received Zepbound at all three dose levels experienced a statistically significant reduction in body weight compared to those who received the placebo, and greater proportions of patients who received Zepbound achieved at least 5% weight reduction compared to the placebo.

“Unfortunately, despite scientific evidence to the contrary, obesity is often seen as a lifestyle choice – something that people should manage themselves,” Dr. Leonard Glass, senior vice president of global medical affairs for Lilly Diabetes and Obesity, added in a statement. “For decades, diet and exercise have been a go-to, but it’s not uncommon for a person to have tried 20 to 30 times to lose weight with this approach. Research now shows that the body may respond to a calorie-deficit diet by increasing hunger and reducing feelings of fullness, making weight loss more difficult. Lilly is aiming to eliminate misperceptions about this disease and transform how it can be managed.”