Eli Lilly and Company The company said on Friday it has applied for U.S. approval of its weight-loss drug Zepbound to treat the most common sleep-related respiratory disease, anticipating regulators make a decision As early as the end of the year.
Patrik Jonsson, Eli Lilly’s president of diabetes and obesity, said in an interview that if approved by the U.S. Food and Drug Administration, the company plans to launch “as soon as possible” in early 2025 for the treatment of so-called obstructive pulmonary disease. Zepbound for sleep apnea.
Also on Friday, the company released more data from two late-stage trials showing Zepbound helped address obstructive sleep apnea (OSA) in nearly half of patients. Eli Lilly releases new data from trial American Diabetes Association 84th Scientific Sessions Friday in Orlando, Florida.
“We’re very excited… I think this actually exceeds the expectations of most outside experts,” Jonsson said of the new data that suggests Zepbound could help address the disease in some patients.
A growing body of evidence suggests further health benefits may come from weight loss and diabetes treatments, which have soared in popularity in the U.S. over the past year but are falling into shortages. The data also paves the way for Eli Lilly to gain broader insurance coverage for Zepbound, which like other weight-loss drugs is not covered by many insurance plans.
The pharmaceutical giant released preliminary results from both studies in April, showing that Zepbound was more effective than placebo in reducing the severity of OSA in obese patients after one year.
OSA refers to interruptions in breathing during sleep due to narrowing or obstruction of the airways. Eli Lilly said in a news release that an estimated 80 million patients in the United States have the disease. About 20 million of them have moderate to severe OSA, but 85% of OSA cases go undiagnosed, Jonsson said.
OSA can cause snoring and excessive daytime sleepiness and lead to serious complications, including stroke and heart failure. Aside from wearing bulky masks, patients with the disease have limited treatment options machine Provide positive airway pressure (PAP) during sleep to achieve normal breathing.
The first study examined weekly injections in adults with moderate to severe OSA and obesity who were not receiving PAP therapy. The second trial tested Zepbound in adults with the same condition, but who were receiving and planning to continue PAP treatment.
The new results showed that 43% of patients taking the highest dose of Zepbound in the first study and 51.5% of patients in the second trial achieved “disease remission,” according to a press release. This compares with 14.9% and 13.6% of patients taking placebo in the two trials.
“This has a huge impact on patients’ lives,” Leonard Glass, senior vice president of diabetes and obesity medical affairs at Eli Lilly and Company, told CNBC. “Imagine not having to use a PAP machine, or not having to worry about waking up again in the middle of the night, or for you to Your partner – does not have to live with someone who has the disease.”
The researchers examined the so-called apnea-hypopnea index, or AHI, records the number of times per hour a person’s breaths show restriction or complete obstruction of the airway. This index is used to assess the severity of obstructive sleep apnea and the effectiveness of treatments for the condition.
According to Eli Lilly, OSA disease remission is defined as patients experiencing fewer than five AHI events per hour. It is also defined as someone who experiences between five and 14 AHI events per hour and scores a certain score on a standard survey designed to measure excessive daytime sleepiness, the company said.
In other new data, the company said that in the first trial, 62.3% of patients taking Zepbound experienced more than a 50% reduction in AHI events, compared with 19.2% of patients taking placebo. Meanwhile, in the second study, 74.3% of subjects taking Eli Lilly’s drug had their AHI reduced by more than 50%, compared with 22.9% of subjects taking a placebo.
Eli Lilly reiterated on Friday that Zepbound met the trial’s primary goal of reducing AHI events.
For people not using PAP machines, Zepbound reduced an average of 27.4 AHI events per hour at 52 weeks. By comparison, patients who received placebo in the first trial experienced an average of 4.8 fewer events per hour.
The drug also led to an average of 30.4 fewer AHI events per hour in patients using the PAP machine at 52 weeks, compared with an average of 6 fewer AHI events per hour in patients taking a placebo in the second study.
Eli Lilly and Company previously announced that the FDA granted Zepbound “Fast Track Designation” Suitable for patients with moderate to severe OSA and obesity. This designation ensures faster review for drugs designed to treat serious or life-threatening conditions and address unmet medical needs.
About The Author
