The U.S. Food and Drug Administration on Wednesday approved Eli Lilly & Co.’s
LLY,
obesity drug Zepbound, which in clinical trials helped patients lose up to 48 pounds on average.
The drug was approved for adults with obesity or overweight and at least one weight-related condition, such as high blood pressure or high cholesterol, the FDA said.
The list price for the drug will be about $1,060, Lilly said in a release Wednesday. Zepbound should be available on U.S. pharmacy shelves right after the Thanksgiving holiday, Rhonda Pacheco, group vice president of marketing for Lilly Diabetes and Obesity, said on a call with reporters Wednesday.
Tirzepatide, the active ingredient in Zepbound, is already approved under the brand name Mounjaro for treatment of Type 2 diabetes.
“In light of increasing rates of both obesity and overweight in the United States, today’s approval addresses an unmet medical need,” Dr. John Sharretts, director of the FDA’s Division of Diabetes, Lipid Disorders, and Obesity, said in a statement. About 70% of adults in the U.S. have obesity or overweight, and many of them have a weight-related condition, the FDA said.
Zepbound is a once-weekly injection, similar to Novo Nordisk’s
NVO,
Wegovy. In clinical trials, about one-third of patients taking the highest dose of Zepbound lost over 58 pounds, Lilly said. The average starting weight was 231 pounds, the company said.
Unlike Wegovy and Ozempic, Zepbound activates both GIP and GLP-1 hormone receptors. Wegovy and Ozempic are focused on the GLP-1 hormone.
Given its efficacy, some analysts see Zepbound becoming a leader in the fast-growing obesity-drug market. “Until additional approvals reach the market as injectables or oral options, we anticipate majority market share for Zepbound,” BMO Capital Markets analyst Evan David Seigerman wrote in a research note Wednesday.
The approval also underscores Lilly’s longer-term potential, Seigerman wrote. “A paradigm shift is upon us, and Lilly is positioned to dominate the U.S. market into the 2030s, given leading assets, execution and injectable manufacturing capacity,” he wrote.
Mounjaro has been one of Lilly’s top-selling products this year, generating $2.96 billion in sales in the first nine months of the year, up from $203 million in the same period last year.
The popularity of new weight-loss drugs has also generated supply issues. Novo Nordisk said last week that it is still struggling to meet demand for Wegovy.
Lilly said on the call Wednesday that it’s working to ensure adequate supply of Zepbound. “You can’t treat the disease without adequate supply,” Lilly Chair and CEO David Ricks said on the call. By the end of this year, the drugmaker’s capacity to produce incretins such as Zepbound will have doubled compared with 2022, he said.
Zepbound’s approval comes amid mounting evidence that the new generation of obesity drugs can also reduce cardiovascular risks. “In the long run, I see this as contributing to both better health and lower costs, which is an unusual opportunity for patients,” Dr. Daniel Skovronsky, chief scientific and medical officer at Eli Lilly, told MarketWatch in an interview in late October.
People who took Zepbound in clinical trials and also dieted and exercised saw reductions in blood pressure, although the drug is not approved to treat that condition, Lilly said in a release Wednesday.
Lilly said it will offer a savings-card program so that people with commercial insurance may be eligible to get the drug for as little as $25 for a one-month prescription. Those with commercial insurance that does not cover Zepbound may be eligible for a roughly 50% discount off the list price, the company said.
But lack of insurance coverage may remain a barrier for some patients who want to access the drug. Medicare is generally prohibited by law from covering prescription drugs for weight loss. On the call Wednesday, Ricks suggested there might be a route around that restriction, noting that Lilly is researching tirzepatide’s potential benefits for other chronic conditions, such as heart failure and sleep apnea. Regulatory approval for the drug in such conditions could expand access to tirzepatide in Medicare, he said. “It would be helpful if the government changed their attitude about treating obesity as well,” he said.
Side effects of the drug can include nausea, diarrhea, vomiting and constipation, Lilly said.
“For decades, diet and exercise have been a go-to, but it’s not uncommon for a person to have tried 20-30 times to lose weight with this approach,” Dr. Leonard Glass, senior vice president of global medical affairs for Lilly Diabetes and Obesity, said in a statement. But calorie restriction can actually make weight loss more difficult, he said. “Lilly is aiming to eliminate misperceptions about this disease and transform how it can be managed.”
Lilly shares were up about 4% Wednesday afternoon and have gained 70% in the year to date, while the S&P 500
SPX
is up 14%.
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