Eli Lilly said Friday that it has filed for U.S. approval of its weight-loss drug Zepbound to treat the most common sleep-disordered breathing disorder and expects regulators to make a decision as early as the end of the year.
If the Food and Drug Administration grants approval, the company plans to bring Zepbound to market “as quickly as possible” in early 2025 for so-called obstructive sleep apnea, Patrik Jonsson, president of Eli Lilly Diabetes and Obesity, said in an interview.
Also on Friday, the company released additional data from two late-stage studies showing that Zepbound helped resolve obstructive sleep apnea (OSA) in nearly half of patients. Eli Lilly presented the new data from the studies on Friday at the 84th Scientific Session of the American Diabetes Association in Orlando, Florida.
“We are super excited. … I think it actually exceeded what most outside experts were hoping for,” Jonsson said of the new data showing that Zepbound may help resolve the disorder in some patients.
This is further evidence that there may be other health benefits associated with a class of weight loss and diabetes treatments that have surged in popularity and fallen into shortage in the U.S. over the past year. The data also paves the way for Eli Lilly to obtain more comprehensive insurance coverage for Zepbound, which, like other weight-loss drugs, is not covered by many insurance plans.
The pharmaceutical giant released initial results from the two trials in April, which showed that Zepbound was more effective than a placebo in reducing the severity of OSA in patients with obesity after one year.
OSA refers to pauses in breathing during sleep due to narrowed or blocked airways. An estimated 80 million patients in the U.S. suffer from the disease, Eli Lilly said in a news release. About 20 million of these people suffer from moderate to severe forms of the disease, but Jonsson says 85% of OSA cases go undiagnosed.
OSA can cause loud snoring and excessive daytime sleepiness and can lead to serious complications such as stroke and heart failure. Patients with this condition have limited treatment options other than having to wear masks while sleeping that are connected to cumbersome machines that generate positive airway pressure (PAP) to allow normal breathing.
The first study examined weekly injections in adults with moderate to severe OSA and obesity who were not receiving PAP therapy. In the second study, Zepbound was tested in adults with the same conditions, but these patients were receiving PAP therapy and planned to continue it.
The new results showed that 43% of people in the first study and 51.5% of patients in the second study who took the highest dose of Zepbound achieved “disease resolution,” according to a news release. This compares to 14.9% and 13.6% of patients who took a placebo in the two studies, respectively.
“This has a huge impact on patients’ lives,” Leonard Glass, Eli Lilly’s senior vice president of medical affairs, diabetes and obesity, told CNBC. “Imagine not having to use a PAP machine, not having to worry about waking up in the middle of the night again, and not having to live with someone who has this disease.”
The researchers came to these conclusions by studying a so-called apnea-hypopnea index (AHI), which records how many 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 treating the condition.
According to Eli Lilly, disease resolution in OSA is defined when a patient experiences fewer than five AHI events per hour. It is also defined as a person who has five to 14 AHI events per hour and scores a certain number on a standard survey measuring excessive daytime sleepiness, the company said.
Among other new data, the company said 62.3% of patients in the first study who took Zepbound experienced a greater than 50% decrease in AHF events, compared to 19.2% of patients taking placebo. Meanwhile, 74.3% of people in the second study who took Eli Lilly’s drug saw a reduction in AHI of more than 50%, compared to 22.9% of participants who received a placebo.
Eli Lilly reiterated Friday that Zepbound met the study’s primary goal of reducing AHF events.
Zepbound resulted in an average of 27.4 fewer AHF events per hour after 52 weeks in people who did not use PAP machines. In comparison, those who received a placebo in the first trial experienced an average reduction of 4.8 events per hour.
The drug also led to an average of 30.4 fewer AHF events per hour in patients receiving PAP machines after 52 weeks, compared to an average reduction of six events per hour in people receiving placebo in 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 medications intended to both treat a serious or life-threatening condition and address an unmet medical need are reviewed more quickly.
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2024-06-21 20:29:35
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