Amid duel with Novo's Wegovy, Lilly's Zepbound homes in on potential FDA sleep apnea nod

Following Novo Nordisk’s recent Wegovy approval to cut heart risks in adults with obesity, Eli Lilly appears to be homing in on the next potential label expansion for its rival GIP/GLP-1 weight-loss med Zepbound.

Late last week, Lilly shared detailed results from its phase 3 SURMOUNT-OSA study, which found that Zepbound at the 10-mg and 15-mg doses aced all primary and secondary endpoints in obese patients with obstructive sleep apnea (OSA), both with or without positive airway pressure (PAP) therapy.

Investigators published the data in The New England Journal of Medicine and presented the full results at the American Diabetes Association’s 84th Scientific Sessions in Orlando, Florida, on Friday.

Zepbound, also known as tirzepatide, won its initial nod in obesity back in November. The molecule is also approved at lower doses in Type 2 diabetes as Mounjaro. In certain countries outside the U.S., the med is known simply as Mounjaro in both its weight loss and diabetes uses.

Given the positive trial results, Lilly said it’s submitted an application for Zepbound in sleep apnea to the U.S. FDA. The company expects a regulatory decision could come as early as the end of the year. The drug currently boasts an agency fast-track designation for moderate-to-severe OSA in patients with obesity.

Taking a deeper look at the results, Zepbound charted a mean reduction of up to 62.8% on the apnea-hypopnea index (AHI), which measures OSA severity by tracking sleep-related breathing issues per hour of sleep. That result translated to about 30 fewer events blocking or restricting a patient’s airflow per hour of sleep versus placebo, Lilly explained in a release.

Further, 43% of patients not on PAP therapy—and 51.5% of patients who used PAP machines—who received the highest dose of Zepbound met the criteria for disease resolution.

Lilly defined disease resolution as an AHI of fewer than five events per hour, or an AHI of 5 to 14 events per hour coupled with an Epworth Sleepiness Scale (ESS) score of up to 10. ESS is a questionnaire used to gauge excessive daytime sleepiness.

Roughly 80 million people in the U.S. struggle with obstructive sleep apnea, and there are no dedicated pharmaceutical treatments on tap to address the underlying cause of the condition, Jeff Emmick, M.D., Ph.D., Lilly’s senior vice president of product development, said in a statement.

OSA can also spur the progression of serious cardiometabolic complications, such as hypertension, coronary heart disease, stroke, heart failure, atrial fibrillation and Type 2 diabetes, Lilly pointed out.

The company added that patients treated with Zepbound in both studies saw “significant improvement” across a slew of secondary endpoints like systolic blood pressure, hypoxic burden and high-sensitivity C-reactive protein (hsCRP)—an inflammation marker—versus placebo.

Lilly’s OSA data mark the second win for tirzepatide this month after three separate doses of the drug helped more than half of metabolic dysfunction-associated steatohepatitis (MASH) patients reduce their fibrosis by at least one stage without their disease worsening.

Aside from sleep apnea and fatty liver disease, Lilly is also testing tirzepatide in heart failure with preserved ejection fraction.

While some analysts have tipped tirzepatide to eventually come out ahead of Novo’s respective diabetes and obesity rivals Ozempic and Wegovy (both underpinned by the GLP-1 molecule semaglutide), Lilly is currently playing catch up with its Danish rival.

Back in March, Novo’s Wegovy became the first weight loss treatment to score an FDA nod to reduce the risk of cardiovascular death, heart attack and stroke in adult patients with cardiovascular disease who have obesity or are overweight.

Mounjaro generated $5.16 billion for Lilly in Type 2 diabetes for all of 2023, while Zepbound brought home $175.8 million.

Novo’s Ozempic, for its part, ginned up roughly $13.8 billion over the same stretch, while Wegovy contributed roughly $4.5 billion to the Danish drugmaker’s 2023 sales haul.