Now, Eli Lilly and Co. is bracing for the onslaught.
The Indianapolis-based company said Wednesday that its newest product, a drug for obesity called Zepbound, will be on pharmacy shelves shortly after Thanksgiving. The company is ramping up manufacturing capacity to avoid possible shortages and to meet potentially huge demand in a nation where more than 40% of adults are classified as obese.
“We are investing in manufacturing like never before,” CEO David Ricks said, “because you can’t treat the disease without adequate supply.”
Zepbound contains the same compound as Lilly’s hugely popular drug for type 2 diabetes, Mounjaro, which launched last year and already has rung up sales of nearly $3 billion in the first nine months of this year.
The Food and Drug Administration, in a widely anticipated decision, on Wednesday approved the drug, also known by its generic name tirzepatide, for weight-loss management. The drug has been shown in clinical trials to help people who are overweight lose at least a quarter of their body weight, or about 60 pounds on average, when combined with intensive diet and exercise.
Lilly said it decided to launch the weight-loss version of the drug under a separate brand name, Zepbound, because patients living with obesity and patients with diabetes have different needs. Separate brands will allow the company to provide educational resources suitable for each group, said Rhonda Pacheco, group vice president of marketing for Lilly Diabetes & Obesity.
Company officials declined to say how they chose the name Zepbound, other than to say it “tested very well” with consumers and health-care professionals.
The demand for Mounjaro has been so brisk that Lilly occasionally has been unable to meet demand. The company invested $450 million this year in its Research Triangle Park facility in North Carolina with additional drug filling, device assembly and packaging capacity for the company’s incretin products, including Mounjaro. Incretins are a group of metabolic hormones that stimulate a decrease in blood glucose levels.
By the end of the year, Lilly will double its capacity to make incretin medicines, compared to a year ago, Ricks said. “You’ll see more announcements in the future and more strategies,” Ricks said.
Mounjaro is still on the FDA’s official drug shortages list, but the company said the drug is available and the FDA list is not up to date. Mounjaro, like Zepbound, is a once-a-week injectable, available in numerous dosage amounts.
Lilly said Wednesday it believes that the “lion’s share” of people currently taking Mounjaro have type 2 diabetes. but did not provide figures. Mounjaro is approved only for diabetes, but physicians are free to prescribe it for weight loss as well, a legal practice known as “off-label prescribing.”
Obesity affects more than 100 million adults and nearly 15 million children in the U.S., and accounts for about $147 billion in annual health care costs, according to the Centers for Disease Control and Prevention.
The question remains whether insurers and health plans will now cover Zepbound, which carries a list price of $1,059.87 per month. Insurers have been reluctant to cover weight-loss drugs, due to the cost and the huge demand.
But Lilly said it is launching Zepbound with a list price that is 20% lower than competitor Novo Nordisk’s popular weight-loss drug called semaglutide. The Novo drug also is sold under two brands: Ozempic for diabetes and Wegovy for weight loss.
Lilly is also introducing a savings card program for people with commercial insurance. The goal is to increase access and reduce price objections from insurers and health plans, the company said.
“Over 50% of the people who live with obesity in America don’t have access (to medications),” said Mike Mason, president of Lilly Diabetes & Obesity. “So our goal, what we’re trying to solve for, is how can we work with other health-care stakeholders to increase the access for people who live with obesity.”