Eli Lilly weight reduction drug Zepbound effective in sleep apnea trials

Eli Lilly on Wednesday said its highly popular weight reduction drug Zepbound showed the potential to treat patients with probably the most common sleep-related respiration disorder in two late-stage clinical trials.

The initial results add to the long list of potential health advantages of weight reduction and diabetes treatments, which have skyrocketed in demand during the last yr despite their high prices and spotty insurance coverage.

Zepbound was more practical than a placebo at reducing the severity of obstructive sleep apnea, or OSA, in patients with obesity after a yr, in response to preliminary data from each trials. OSA refers to interrupted respiration during sleep on account of narrowed or blocked airways. The pharmaceutical giant said it plans to present the outcomes at an upcoming medical conference and submit them to the Food and Drug Administration and regulators in other countries in mid-2024.

Eli Lilly previously announced that the FDA granted Zepbound “fast track designation” for patients with moderate-to-severe OSA and obesity. That designation ensures that drugs that intend to each treat a serious or life-threatening condition and fill an unmet medical need get reviewed more quickly.

The outcomes are an early sign of hope for the estimated 80 million patients within the U.S. who experience OSA, 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 response to Eli Lilly.

OSA can result in excessive daytime sleepiness and loud snoring, in addition to contribute to serious complications, including hypertension, stroke and heart failure. Patients with the condition have limited treatment options outside of cumbersome and infrequently uncomfortable machines that provide positive airway pressure, or PAP, to permit for normal respiration.

“Addressing this unmet need head-on is critical, and while there are pharmaceutical treatments for the excessive sleepiness related to OSA, [Zepbound] has the potential to be the primary pharmaceutical treatment for the underlying disease,” Dr. Jeff Emmick, Eli Lilly’s senior vp of product development, said in the discharge on Wednesday.

Zepbound has slipped into shortages since receiving approval within the U.S. for weight management in November. The lively ingredient in Zepbound, often called tirzepatide, can be approved under the brand name Mounjaro for diabetes.

Mounjaro and other diabetes drugs are typically covered by insurance, while Zepbound and other weight reduction drugs will not be. But the brand new data in sleep apnea patients gives Eli Lilly a “pathway to gaining Medicare Part D coverage for Zepbound,” even before any changes to the federal program’s coverage of obesity treatments, JPMorgan Chase analyst Chris Schott wrote in a note Wednesday.

Under latest guidance issued in late March, Medicare can cover certain weight reduction drugs so long as they receive FDA approval for an added health profit. Medicare prescription drug plans administered by private insurers, often called Part D, currently cannot cover those drugs for weight reduction alone.

Schott added that the brand new data gives Eli Lilly a path to extend using Zepbound amongst men. He said the corporate has suggested that men could also be more prone to use a so-called GLP-1 drug comparable to Zepbound for sleep apnea in comparison with obesity.

Eli Lilly’s Zepbound works by imitating two naturally produced gut hormones called GLP-1 and GIP. GLP helps reduce food intake and appetite. GIP, which also suppresses appetite, can also improve how the body breaks down sugar and fat.

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 guage the severity of obstructive sleep apnea and the effectiveness of treatments for the condition. 

In each sub-studies, Zepbound was superior to the placebo in reducing AHI, which was the predominant goal of the trials.

The primary study evaluated the drug in adults with moderate-to-severe obstructive sleep apnea and obesity who weren’t on PAP therapy.

Individuals who took Zepbound had a mean of 27.4 fewer AHI events per hour at 52 weeks, compared with a mean reduction of 4.8 events per hour for the placebo, in response to the outcomes. 

Zepbound also met the trial’s second goal, resulting in an overall AHI reduction of 55% compared with a decrease of 5% for the placebo, the outcomes say.

The second study tested Zepbound in adults with the identical conditions, but those patients were on and planned on continuing PAP therapy.

Individuals who took Zepbound had a mean of 30.4 fewer AHI events per hour at 52 weeks, compared with a mean reduction of 6 events per hour for the placebo. 

Zepbound led to an overall AHI reduction of nearly 63%, compared with a decrease of greater than 6% for the placebo.

The outcomes blew past Wall Street’s expectations. Investors largely deemed a 50% reduction as the brink to contemplate Eli Lilly’s trials a hit. The roughly 60% improvement shows “outsized advantages,” Deutsche Bank analyst James Shin wrote in a note Wednesday.

Across the 2 studies, Zepbound helped patients lose around 20% of their weight. But Eli Lilly noted that men are known to realize less weight reduction than women with therapies like Zepbound.

In a note on Wednesday, Morgan Stanley analyst Terence Flynn called that weight reduction encouraging and said the firm expected 15% to 18% weight reduction within the trial. Morgan Stanley views “this as one other positive data point supporting the efficacy profile of tirzepatide,” Flynn said.