Eli Lilly The US drugmaker said on Friday it has applied for US approval of weight-loss drug Zibbond to treat the most common sleep-related breathing disorder, and expects regulators to make a decision as early as the end of the year.
Patrick Johnson, president of Eli Lilly Diabetes and Obesity, said in an interview that if the Food and Drug Administration approves it, the company plans to launch Zepbound for so-called obstructive sleep apnea “as quickly as possible” at the beginning of 2025. .
Also on Friday, the company released additional data from two late-stage trials showing that Zepbound helped resolve obstructive sleep apnea, or OSA, in about half of patients. Eli Lilly presented the new data from the trials at the American Diabetes Association's 84th Scientific Session in Orlando, Florida, on Friday.
“We're very excited,” Johnson said of the new data showing that Zepbound can help resolve the disorder in some patients. “I think it's actually gone beyond what most outside experts had hoped.”
This adds to growing evidence that there may be other health benefits associated with a class of weight loss and diabetes treatments that have risen and fallen in popularity in the United States over the past year. The data also paves the way for Eli Lilly to obtain broader insurance coverage for Zepbound, which, like other weight loss drugs, is not covered by many insurance plans.
The pharmaceutical giant in April released preliminary results from the two studies, which showed that Zepbound was more effective than placebo in reducing the severity of sleep apnea in obese patients after a year.
Obstructive sleep apnea (OSA) refers to the cessation of breathing during sleep due to narrowing or blockage of the airways. Eli Lilly said in a press release that an estimated 80 million patients in the United States suffer from this disease. About 20 million of these people have moderate to severe forms of the disease, but 85% of sleep apnea cases go undiagnosed, according to Johnson.
Obstructive sleep apnea (OSA) can lead to loud snoring and excessive daytime sleepiness, and it contributes to serious complications, including stroke and heart failure. Patients with this condition have limited treatment options outside of wearing masks connected to cumbersome machines during sleep that provide positive airway pressure, or PAP, to allow normal breathing.
The first study examined weekly injections in adults with moderate to severe obstructive sleep apnea (OSA) and obesity who were not on PAP treatment. The second trial tested Zepbound in adults with the same conditions, but these patients were receiving treatment and planned to continue PAP treatment.
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 “remission of the disease,” according to the statement. This compares to 14.9% and 13.6% of patients who took placebo in the two trials, respectively.
“This has significant implications for patients' lives,” Leonard Glass, M.D., senior vice president of medical affairs for diabetes and obesity, 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 not having to have your partners – not having to live with someone who has this condition.”
The researchers arrived at these conclusions by examining what's called the apnea-hypopnea index, or AHI, which records the number of times per hour that a person's breathing shows their airway is constricted or completely blocked. The index is used to evaluate the severity of obstructive sleep apnea and the effectiveness of treatments for this condition.
Resolution of OSA is defined as a patient experiencing fewer than five AHI events per hour, according to Eli Lilly. It is also defined as someone who has between 5 and 14 AHI events per hour and scores a certain number on a standardized survey designed to measure excessive daytime sleepiness, the company said.
Among other new data, the company said 62.3% of patients in the first trial who took Zepbound saw a more than 50% reduction in AHI events, compared to 19.2% of those who took placebo. Meanwhile, 74.3% of people in the second study who took Eli Lilly saw a more than 50% reduction in AHI, compared to 22.9% of participants who received a placebo.
Eli Lilly confirmed on Friday that Zepbound achieved the trial's main goal, which was to reduce AHI events.
Zepbound reduced the number of AHI events by 27.4 per hour over 52 weeks in people who did not use PAP devices. This compares to an average reduction of 4.8 events per hour for those who received a placebo in the first trial.
The drug also resulted in an average reduction of AHI events of 30.4 per hour over 52 weeks in patients who were using PAP devices, 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 has granted Zepbound “Fast Track Designation” for patients with moderate to severe OSA and obesity. The designation ensures that medications intended to treat a serious or life-threatening condition are reviewed and unmet medical needs are addressed more quickly.
