Eli Lilly announced on Friday that it has applied for U.S. approval of its weight-loss drug Zepbound to treat probably the most common sleep-related respiration disorder and expects regulators make a call already at the tip of the yr.
If the corporate receives approval from the U.S. Food and Drug Administration (FDA), it plans to bring Zepbound to marketplace for obstructive sleep apnea “as soon as possible” in early 2025, Patrik Jonsson, president of Eli Lilly Diabetes and Obesity, said in an interview.
Also on Friday, the corporate released additional data from two late-stage studies showing that Zepbound helped reverse obstructive sleep apnea (OSA) in nearly half of patients. Eli Lilly presented the brand new data from the studies on the 84th Scientific Meeting of the American Diabetes Association in Orlando, Florida, on Friday.
“We are absolutely thrilled. … I think it even exceeds the expectations of most outside experts,” Jonsson said of the brand new data showing that Zepbound may help cure the disorder in some patients.
This is further evidence that a gaggle of weight-loss and diabetes drugs that surged in popularity after which fell into shortage within the U.S. last yr can have other health advantages. The data also clears the way in which for Eli Lilly to hunt broader insurance coverage for Zepbound, which, like other weight-loss drugs, will not be covered by many insurers.
The pharmaceutical giant published initial results from the 2 studies in April, which showed that Zepbound was simpler than a placebo in reducing the severity of OSA in patients with obesity after one yr.
OSA refers to pauses in respiration during sleep attributable to narrowed or blocked airways. An estimated 80 million patients within the United States suffer from the disease, Eli Lilly said in a press release. About 20 million of those people suffer from moderate to severe types of the disease, but 85 percent of OSA cases remain undiagnosed, in accordance with Jonsson.
OSA may cause loud snoring and excessive daytime sleepiness and may contribute to serious complications similar to stroke and heart failure. Patients with this condition have limited treatment options apart from wearing masks which are tied to cumbersome machinery during sleep, which create positive airway pressure (PAP) to enable normal respiration.
The first study evaluated weekly injection in adults with moderate to severe OSA and obesity who weren’t receiving PAP therapy. The second study tested Zepbound in adults with the identical conditions but who were receiving PAP therapy and planned to proceed that therapy.
The recent results showed that 43 percent of participants in the primary study and 51.5 percent of patients within the second study who took the very best dose of Zepbound achieved a “cure of disease,” in accordance with a press release. By comparison, this was the case for 14.9 percent and 13.6 percent of patients who took a placebo within the two studies, respectively.
“This has a huge impact on patients' lives,” Leonard Glass, Eli Lilly's senior vice chairman of medical affairs, diabetes and obesity, told CNBC. “Imagine not having to use a PAP machine or worrying about waking up in the middle of the night, or worrying about your partners – you wouldn't have to live with someone who has this disease.”
The researchers got here to those conclusions by examining a so-called Apnea-hypopnea indexor AHI, which indicates how repeatedly per hour an individual's respiration has a restricted or completely blocked airway. The index is used to guage the severity of obstructive sleep apnea and the effectiveness of treatment for the condition.
According to Eli Lilly, disease resolution in OSA is defined when a patient has fewer than five AHI events per hour. According to the corporate, additionally it is defined when an individual has five to 14 AHI events per hour and meets a certain number on a typical survey measuring excessive daytime sleepiness.
Among other things, the corporate said that 62.3% of patients in the primary study who took Zepbound experienced a greater than 50% reduction in AHI events, compared with 19.2% of patients on placebo. Meanwhile, 74.3% of individuals within the second study who took Eli Lilly's drug experienced a greater than 50% reduction in AHI, compared with 22.9% of participants who received a placebo.
Eli Lilly reiterated on Friday that Zepbound had achieved the study's primary goal of reducing AHI events.
Zepbound resulted in a mean of 27.4 fewer AHI events per hour after 52 weeks in people not connected to PAP machines. This compares with a mean reduction of 4.8 events per hour in those that received a placebo in the primary study.
The drug also resulted in a mean of 30.4 fewer AHI events per hour after 52 weeks in patients connected to PAP machines. This compared with a mean reduction of six events per hour in individuals who received a placebo within the second study.
Eli Lilly had previously announced that the FDA Zepbound “Fast-track designation” for patients with moderate to severe OSA and obesity. The designation ensures that drugs intended to each treat a serious or life-threatening condition and address an unmet medical need are reviewed more quickly.
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