Chicago, IL – The U.S. Food and Drug Administration (FDA) has approved pharmaceutical company Eli Lilly’s new diabetes and weight loss drug Zepbound (tirzepatide), further heating up competition in the lucrative obesity treatment market.
Zepbound Approved for Weight Loss in Adults
On Friday, regulators signed off on Zepbound as an adjunct treatment option for chronic weight management in adults living with excess weight or obesity. The once-weekly injectable medication was shown in clinical trials to help patients lose up to 18% of their body weight over 72 weeks.
“Obesity is a chronic disease that affects people of all ages, and the rates of this disease continue to rise. Today’s approval provides adults living with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” said John Sharretts, M.D., deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research.
The approval comes shortly after Eli Lilly’s other promising diabetes drug Mounjaro (tirzepatide) was authorized for weight management in the UK on Wednesday. Both medications are GLP-1 receptor agonists, a class of injectable drugs that help lower blood sugar and reduce appetite.
Zepbound Expected to Launch by End of 2023
Zepbound will likely be available to U.S. patients by the end of this year. It carries a monthly list price of $1,059.87 for a 5 mg dose and $1,349.02 for a 10 mg dose, making it cheaper than the $1,349 monthly cost of rival drug Wegovy but pricier than Ozempic and Mounjaro.
The most common side effects of Zepbound are nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dizziness, and hypoglycemia in patients with type 2 diabetes. The drug also comes with warnings about increased heart rate, gallbladder problems, kidney failure, and suicidal behavior or thinking.
Of note, animal studies showed Zepbound caused thyroid C-cell tumors at clinically relevant exposures, prompting a boxed warning. Providers have been advised to monitor patients for thyroid tumors while on treatment.
Huge Potential Seen for Obesity Drugs
Analysts project the global obesity treatment market could swell to $100 billion by 2035 as rates of obesity and overweight continue trending upwards in the U.S.
“We believe obesity is set to become the next multi-billion dollar category in pharmaceuticals, and Lilly is poised to take share versus Novo Nordisk in this market on the back of its GLP-1 franchise,” said BMO Capital Markets analyst Evan Seigerman.
The excitement around using diabetes medications for weight loss took off last year when Novo Nordisk’s Ozempic and Wegovy won FDA approval for chronic weight management.
Novo Dominates But Faces Growing Competition
The Danish pharmaceutical giant has dominated the U.S. obesity drug space, racking up over $900 million in Wegovy sales in Q3 2022 alone, with around 95% coming from the lucrative American market. However, shortages resulting from the medication’s runaway demand have hindered growth.
Novo Nordisk CEO Lars Fruergaard Jørgensen said the company could further concentrate U.S. expansion and drug development there if proposed regulations around exclusivity periods were passed in Europe.
“Our success in the U.S. means that we are slower getting going in Europe because it’s just less attractive,” Jørgensen told the Financial Times.
Lilly’s entry with Zepbound and Mounjaro represents the first major threat to Novo’s supremacy, giving providers and patients more options.
Consumer Habits Reshaping Food Industry
The incredible demand for anti-obesity medications signals shifting consumer priorities around health and wellness. As the average American’s weight drops, large food retailers and manufacturers are being forced to adapt.
Walmart executives acknowledged they anticipate grocery purchases decreasing as customers buy less food by volume while dieting. Other suppliers like Nestle are working on lower-calorie “companion products” to suit changing nutritional requirements.
While the brands leading the charge stand to profit immensely from the ballooning weight loss market, those slow to innovate may end up losing loyal customers over time.