Eli Lilly on Friday said it applied for U.S. approval of its weight reduction drug Zepbound for the treatment of essentially the most common sleep-related respiratory disorder and expects regulators to make a choice as early as the tip of the yr.
If cleared by the Food and Drug Administration, the corporate plans to launch Zepbound for so-called obstructive sleep apnea “as quickly as we are able to” firstly of 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 trials showing that Zepbound helped resolve obstructive sleep apnea, or OSA, in almost half of patients. Eli Lilly presented the brand new data from the trials on the American Diabetes Association’s 84th Scientific Sessions in Orlando, Florida, on Friday.
“We’re super excited. … I believe it actually went beyond what most external experts were hoping for,” Jonsson said of the brand new data demonstrating that Zepbound may also help resolve the disorder in some patients.
It adds to growing evidence that there could possibly be further health advantages tied to a category of weight reduction and diabetes treatments which have soared in popularity and slipped into shortages within the U.S. over the past yr. The info also paves the way in which for Eli Lilly to realize broader insurance coverage for Zepbound, which, like other weight reduction drugs, will not be covered by many insurance coverage.
The pharmaceutical giant in April released initial results from the 2 studies, which showed that Zepbound was more practical than a placebo at reducing the severity of OSA in patients with obesity after a yr.
OSA refers to interrupted respiratory during sleep as a result of narrowed or blocked airways. An estimated 80 million patients within the U.S. experience the disease, Eli Lilly said in a press release. Around 20 million of those people have moderate-to-severe types of the disease, but 85% of OSA cases go undiagnosed, in line with Jonsson.
OSA can result in loud snoring and excessive daytime sleepiness, in addition to contribute to serious complications, including stroke and heart failure. Patients with the condition have limited treatment options outside of wearing masks attached to cumbersome machines while sleeping that provide positive airway pressure, or PAP, to permit for normal respiratory.
The primary study examined the weekly injection in adults with moderate-to-severe OSA and obesity who weren’t on PAP therapy. The second trial tested Zepbound in adults with the identical conditions, but those patients were on and planned on continuing PAP therapy.
The brand new results showed that 43% of individuals in the primary study and 51.5% of patients within the second trial who took the best dose of Zepbound achieved “disease resolution,” in line with a release. That compares with 14.9% and 13.6% of patients who took a placebo within the two trials, respectively.
“This has huge impacts on patients’ lives,” Leonard Glass, senior vice chairman of medical affairs at Eli Lilly, diabetes and obesity, told CNBC. “Imagine not having to make use of a PAP machine, or not having to fret about waking up again in the midst of the night, or to your partners — not having to live with anyone with this condition.”
Researchers got here to those conclusions by examining a so-called apnea-hypopnea index, or AHI, which records the variety of times per hour an individual’s respiratory shows a restricted or completely blocked airway. The index is used to judge the severity of obstructive sleep apnea and the effectiveness of treatments for the condition.
Disease resolution for OSA is defined as a patient having fewer than five AHI events per hour, in line with Eli Lilly. It is usually defined as an individual having five to 14 AHI events per hour and scoring a certain number on a typical survey designed to measure excessive daytime sleepiness, the corporate said.
Amongst other latest data, the corporate said 62.3% of patients in the primary trial who took Zepbound saw a greater than 50% reduction in AHI events, compared with 19.2% of those on placebo. Meanwhile, 74.3% of individuals within the second study who took Eli Lilly’s drug saw a greater than 50% reduction in AHI, compared with 22.9% of participants who received a placebo.
Eli Lilly on Friday reiterated that Zepbound met the principal goal of the trial, which was reducing AHI events.
Zepbound led to a mean of 27.4 fewer AHI events per hour at 52 weeks in individuals who weren’t on PAP machines. That compares to a mean reduction of 4.8 events per hour for many who received a placebo in the primary trial.
The drug also led to a mean of 30.4 fewer AHI events per hour at 52 weeks in patients who were on PAP machines, compared with a mean reduction of six events per hour for people on the placebo within the second study.
Eli Lilly previously announced that the FDA granted 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 fill an unmet medical need get reviewed more quickly.
