Eli Lilly on Wednesday said its highly popular weight loss drug Zepbound showed the potential to treat patients with the most common sleep-related breathing disorder in two late-stage clinical trials. The initial results add to the long list of potential health benefits of weight loss and diabetes treatments, which have skyrocketed in demand over the last year despite their high prices and spotty insurance coverage. Zepbound was more effective than a placebo at reducing the severity of obstructive sleep apnea, or OSA, in patients with obesity after a year, according to preliminary data from both trials. The pharmaceutical giant said it plans to present the results at an upcoming medical conference and submit it to the U. S. Food and Drug Administration and regulators in other countries in the middle of the year. Eli Lilly previously announced that the FDA granted Zepbound “fast track designation” for patients with moderate-to-severe OSA and obesity. That designation expedites the review of drugs that treat a serious or life-threatening condition and fill an unmet medical need. The results are an early sign of hope for the estimated 80 million patients in the U. S. suffering from OSA, which refers to interrupted breathing during sleep due to narrowed or blocked airways. Around 20 million of those people have moderate-to-severe forms of the disease, but 85% of OSA cases go undiagnosed, according to Eli Lilly. OSA can lead to excessive daytime sleepiness, loud snoring and can contribute to serious complications, including hypertension, stroke and heart failure. Patients with the condition have limited treatment options outside of cumbersome and often uncomfortable machines that provide positive airway pressure, or PAP, to allow for normal breathing.”Addressing this unmet need head-on is critical, and while 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,” Dr. Jeff Emmick, Eli Lilly’s senior vice president of product development, said in a release on Wednesday. Zepbound has slipped into shortages since receiving approval in the U. S. for weight management in November. The active ingredient in Zepbound, known as tirzepatide, is also approved under the brand name Mounjaro for diabetes. The two phase three trials, both called SURMOUNT-OSA, tested Zepbound in two groups of patients. Notably, 70% of participants across the studies were men. Researchers specifically examined how much the weekly injection reduced the so-called apnea-hypopnea index, or AHI, which records the number of times per hour a person’s breathing shows a restricted or completely blocked airway. The index is used to evaluate the severity of obstructive sleep apnea and the effectiveness of treatments for the condition. In both sub-studies, Zepbound was superior to placebo in reducing AHI, which was the main goal of the trials.
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Article Link: https://www.cnbc.com/2024/04/17/eli-lillys-zepbound-shows-promise-as-sleep-apnea-treatment-in-trial.html
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