Eli Lilly (LLY.N), said on Wednesday its weight-loss drug helped reduce episodes of irregular breathing associated with a common sleep-related disorder in two late-stage trials, paving the way for expanding use of the drug.
The drug cut the frequency of irregular breathing episodes by as much as 63% across the two studies.
The trial results add to a growing body of clinical evidence that suggests popular GLP-1 drugs such as Lilly’s Zepbound and Novo Nordisk’s Wegovy have medical benefits beyond diabetes and weight loss.
The U.S. Food and Drug Administration approved Wegovy last month for lowering the risk of stroke and heart attack in overweight or obese adults who do not have diabetes.
Shares of the Indianapolis-based drugmaker rose 1.6% to $758.64 in early trading. Lilly’s shares have risen 26% since January.
Lilly evaluated its GLP-1 drug called tirzepatide, sold as Zepbound for obesity and Mounjaro for type 2 diabetes, in patients with obstructive sleep apnea and obesity.
In the first study, patients who received tirzepatide showed a 55% reduction in the frequency of irregular breathing episodes. Patients in the second study, which tested the drug in combination with continuous positive airway pressure (PAP) therapy, experienced an average 62.8% drop in events of irregular breathing.
The data could boost Lilly’s chances of insurance coverage under U.S. government-backed Medicare plans for seniors, Wall Street analysts said.
Obstructive sleep apnea, which is characterized by brief interruptions in breathing during sleep, affects roughly 1 billion people globally, according to a 2019 study published in The Lancet.
There are currently no drugs approved to treat the disease, although use of PAP therapy devices, which deliver constant air pressure to prevent airways from collapsing, is common.
Resmed’s continuous PAP therapy devices are among those approved by the FDA. Shares of the company declined 6% to $174 in early trading.
Lilly plans to submit data to the U.S. FDA and other regulatory agencies starting mid-2024.
The data could help Lilly get approval for Zepbound as a treatment for sleep apnea and obesity by early 2025, said Leerink analyst David Risinger.
Two analysts said they wanted to see whether Zepbound showed benefits beyond weight-loss once the full data is released, such as any improvements in blood pressure levels in patients – one of the secondary goals for Lilly’s studies.
Investors are also interested in knowing if the drug “works in thinner individuals” with the condition, said Cantor Fitzgerald analyst Louise Chen.
EXPANDING AVENUES
Men, who are known to achieve less weight loss than women with incretin therapies such as tirzepatide, made up about 70% of the patient population across the two studies, Lilly said.
The results could give Lilly a path to increase the use of its drug among males, said JP Morgan analyst Chris Schott.
Lilly did not provide detailed results for the secondary goals of the studies but said it plans to present detailed data at a medical conference in June.
Zepbound, which was approved for chronic weight management late last year, can be prescribed to overweight patients with at least one co-morbid condition such as obstructive sleep apnea or cardiovascular disease.
Most doses of the drug are expected to be in limited availability through the second quarter, according to the U.S. FDA’s website.
Reporting by Bhanvi Satija in Bengaluru; Editing by Sriraj Kalluvila, Shinjini Ganguli and Devika Syamnath