FDA approves Eli Lilly’s weight reduction drug Zepbound for sleep apnea

The Food and Drug Administration on Friday approved Eli Lilly‘s blockbuster weight reduction drug Zepbound for treating patients with probably the most common sleep-related respiration disorder, expanding its use and possibly its insurance coverage within the U.S.

The weekly injection is now the primary drug treatment option cleared for patients with obesity and moderate-to-severe obstructive sleep apnea, or OSA, which refers to respiration interrupted during sleep attributable to narrowed or blocked airways. Zepbound ought to be used together with a reduced-calorie weight-reduction plan and increased physical activity, the FDA noted in a release.

An estimated 80 million patients within the U.S. experience the disease, in keeping with Eli Lilly. Roughly 20 million of those people have moderate-to-severe types of the disease, but 85% of cases go undiagnosed, the corporate told CNBC earlier this 12 months.

“Too often, OSA is brushed off as ‘just snoring’ — nevertheless it’s excess of that,” said Julie Flygare, president and CEO of Project Sleep, a nonprofit advocating for sleep health and sleep disorders, in a release from Eli Lilly. “It is vital to grasp OSA symptoms and know that treatments can be found, including latest options like Zepbound. We hope this may spark more meaningful conversations between patients and health care providers and ultimately lead to higher health outcomes.” 

Eli Lilly expects to launch the drug for OSA at the start of next 12 months. It’s the primary approval beyond obesity treatment for Zepbound, which entered the market late last 12 months and can also be being tested for several other obesity-related conditions, comparable to fatty liver disease. Tirzepatide, the energetic ingredient in Zepbound, has been sold on the U.S. marketplace for longer because the diabetes drug Mounjaro.

The agency’s decision could pave the way in which for Eli Lilly to realize broader insurance coverage for Zepbound, which, like other weight reduction drugs, isn’t covered by many insurance coverage. That features the federal Medicare program, which only covers obesity drugs in the event that they are approved and prescribed for an added health profit.

The approval also backs up mounting evidence that there could possibly be further health advantages tied to GLP-1s, a category of weight reduction and diabetes treatments which have soared in popularity and slipped into shortages over the past 12 months. Notably, Zepbound’s primary rival, the load loss drug Wegovy from Novo Nordisk, isn’t approved for OSA.

Zepbound could possibly be a priceless latest treatment option for patients with OSA, which might result in loud snoring and excessive daytime sleepiness, and may 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 that provide positive airway pressure, or PAP, to permit for normal respiration.

Eli Lilly in April released initial results from the 2 clinical trials, which showed that Zepbound was more practical than a placebo at reducing the severity of OSA in patients with obesity after a 12 months.

In June, Eli Lilly released additional data from the studies showing that Zepbound helped
resolve OSA in almost half of patients. The primary study examined the weekly injection in adults with moderate-to-severe OSA and obesity who weren’t on PAP therapy. The second tested Zepbound in adults with the identical conditions, but those participants were on and planned on continuing PAP therapy.

The information 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 keeping with the corporate. That compares with 14.9% and 13.6% of patients who took a placebo within the two trials, respectively.

Researchers got here to those conclusions by examining an 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.

Disease resolution for OSA is defined as a patient having fewer than five AHI events per hour, the corporate said. It’s also 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, in keeping with Eli Lilly.