Eli Lilly On Friday it said it applied for U.S. approval of its weight-loss drug Zepbound for the treatment of the most common sleep-related breathing disorder and expects regulators to make a decision by the end of the year.
If cleared by the Food and Drug Administration, the company plans to launch Zepbound for so-called obstructive sleep apnea “as quickly as possible” in early 2025, Patrik Jonsson, president of Eli Lilly Diabetes and Obesity, said in an interview. .
Also on Friday, the company released additional data from two late-stage trials showing that Zepbound helped resolve obstructive sleep apnea, or OSA, in nearly half of patients. Eli Lilly presented the new trial data at the American Diabetes Association's 84th Scientific Session in Orlando, Florida, on Friday.
“We're very excited… I think it actually went beyond what most outside experts expected,” Jonsson said of new data showing Zepbound can help resolve the disorder in some patients.
It adds to growing evidence that there may be more health benefits linked to a class of weight loss and diabetes treatments whose popularity has skyrocketed and led to shortages in the U.S. over the past year. The data also paves the way for Eli Lilly to get broader insurance coverage for Zepbound, which, like other weight-loss drugs, is not covered by many insurance plans.
The pharmaceutical giant published initial results from the two studies in April, which showed that Zepbound was more effective than a placebo in reducing the severity of OSA in patients with obesity after one year.
OSA refers to interrupted breathing during sleep due to narrowed or blocked airways. An estimated 80 million patients in the United States experience the disease, Eli Lilly said in a news release. About 20 million of those people suffer from moderate to severe forms of the disease, but 85% of OSA cases go undiagnosed, according to Jonsson.
OSA can cause loud snoring and excessive daytime sleepiness, as well as contribute to serious complications such as stroke and heart failure. Patients with this condition have limited treatment options other than wearing masks connected to cumbersome machines while they sleep that provide positive airway pressure, or PAP, to allow normal breathing.
The first study examined weekly injection in adults with moderate to severe OSA and obesity who were not on PAP therapy. The second trial tested Zepbound in adults with the same conditions, but those patients were receiving and planned to continue PAP therapy.
The new results showed that 43% of people in the first study and 51.5% of patients in the second trial who took the highest dose of Zepbound achieved “disease resolution,” according to a statement. That compares with 14.9% and 13.6% of patients who took a placebo in the two trials, respectively.
“This has a huge impact on patients' lives,” Leonard Glass, Eli Lilly's senior vice president of medical affairs, diabetes and obesity, told CNBC. “Imagine not having to use a PAP machine, or not having to worry about waking up in the middle of the night again, or your partners, not having to live with someone with this condition.”
The researchers reached those conclusions by examining the so-called apnea-hypopnea index, or AHI, which records the number of times per hour that a person's breathing shows a restricted or completely blocked airway. The index is used to evaluate the severity of obstructive sleep apnea and the effectiveness of treatments for the condition.
OSA disease resolution is defined as a patient having fewer than five AHI events per hour, according to Eli Lilly. It is also defined as a person who has five to 14 AHI events per hour and scores a certain number on a standard survey designed to measure excessive daytime sleepiness, the company said.
Among other new data, the company said that 62.3% of patients in the first trial taking Zepbound experienced a greater than 50% reduction in AHI events, compared to 19.2% of those taking placebo . Meanwhile, 74.3% of people in the second study who took Eli Lilly's drug experienced a more than 50% reduction in AHI, compared to 22.9% of participants who received a placebo.
Eli Lilly reiterated on Friday that Zepbound met the primary goal of the trial, which was to reduce IAH events.
Zepbound caused an average of 27.4 fewer IAH events per hour at 52 weeks in people not using PAP machines. That compares with an average reduction of 4.8 events per hour for those who received a placebo in the first trial.
The drug also caused an average of 30.4 fewer AHI events per hour at 52 weeks in patients using Pap machines, compared with an average reduction of six events per hour for people taking placebo in the second study.
Eli Lilly previously announced that the FDA granted Zepbound “fast track designation” for patients with OSA and moderate to severe obesity. That designation ensures that drugs intended to treat a serious or life-threatening condition and meet an unmet medical need are reviewed more quickly.
