Eli Lilly said Wednesday its wildly popular weight-loss drug Zepbound shows the potential to treat patients with essentially the most common medical conditions sleep-disordered respiration in two advanced clinical trials.
The early findings add to the long list of potential health advantages of weight reduction and diabetes treatments, demand for which has skyrocketed within the last yr despite their high prices and little insurance coverage.
Zepbound was simpler than a placebo in reducing the severity of the disease obstructive sleep apnea, or OSA, in patients with obesity after one yr, in response to preliminary data from each studies. The pharmaceutical giant said it plans to present the findings at an upcoming medical conference and present them to the U.S. Food and Drug Administration and regulators in other countries by mid-year.
Eli Lilly previously announced that the FDA approved Zepbound “Fast Track Designation” for patients with moderate to severe OSA and obesity. This designation expedites the review of medicines that treat a serious or life-threatening condition and address an unmet medical need.
The findings are a primary sign of hope for the estimated 80 million patients within the United States who are suffering from OSA, interrupted respiration during sleep because of narrowed or blocked airways. According to Eli Lilly, about 20 million of those people have moderate to severe types of the disease, but 85% of OSA cases go undiagnosed.
OSA may cause this excessive daytime sleepiness, loud snoring and might result in serious complications resembling hypertension, stroke and heart failure. There are limited treatment options available for patients with this condition, that are cumbersome and sometimes uncomfortable machinery which produce positive airway pressure (PAP) to permit normal respiration.
“It is critical to directly address this unmet need, and although there are pharmaceutical treatments for the excessive sleepiness associated with OSA, [Zepbound] has the potential to be the first pharmaceutical treatment for the underlying disease,” said Dr. Jeff Emmick, senior vice chairman of product development at Eli Lilly, in a press release on Wednesday.
There have been shortages since Zepbound was approved within the U.S. for weight management in November. The energetic ingredient in Zepbound, often called tirzepatide, can be approved for diabetes under the brand name Mounjaro.
First test results
In the 2 Phase III studies, each called SURMOUNT-OSA, Zepbound was tested in two groups of patients. Notably, 70% of participants in all studies were men.
The researchers specifically examined how much the weekly injection reduced the so-called Apnea-hypopnea index, or AHI, which records the variety of times per hour an individual's respiration shows a restricted or completely blocked airway. The index is used to judge the severity of obstructive sleep apnea and the effectiveness of treating the condition.
In each sub-studies, Zepbound was superior to placebo in reducing AHI, the foremost goal of the studies.
The first study evaluated the drug in adults with moderate to severe obstructive sleep apnea and obesity who weren’t receiving PAP therapy.
People who took Zepbound had a mean of 27.4 fewer AHF events per hour after 52 weeks, in comparison with a mean reduction of 4.8 events per hour within the placebo group.
Zepbound also met the study's second objective, leading to an overall reduction in AHI of 55%, in comparison with a 5% reduction for placebo.
In the second study, Zepbound was tested in adults with the identical conditions, but these patients were receiving PAP therapy and planned to proceed it.
People who took Zepbound had a mean of 30.4 fewer AHF events per hour after 52 weeks, in comparison with a mean reduction of 6 events per hour within the placebo group.
Zepbound resulted in an overall reduction in AHI of virtually 63%, in comparison with a discount of greater than 6% for placebo.
In each studies, Zepbound helped patients lose about 20% of their weight. However, Eli Lilly noted that men are known to attain less weight reduction than women with therapies like Zepbound.
Eli Lilly's Zepbound mimics two naturally produced gut hormones called GLP-1 and GIP. GLP helps reduce food intake and appetite. GIP, which also suppresses appetite, may additionally improve the best way the body breaks down sugar and fat.
Especially Eli Lilly's foremost rival Novo Nordisk isn’t studying its own weight reduction and diabetes medications in patients with sleep apnea.
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