预约演示

Eli Lilly's tirzepatide scores again, this time in 2 sleep apnea trials

2024-04-17

临床结果临床3期快速通道上市批准优先审批

Two trials have shown that Eli Lilly's Zepbound (tirzepatide) can cut obstructive sleep apnea (OSA) events in obese patients with moderate-to-severe OSA.

In addition to their acclaiEli LillyacyZepbound dtirzepatide obesity, obstructive sleep apnea (OSA)ion for their potential to treat a variety of otheOSAommon disorders.

Add another to the list as two trials have showndiabetesi LilobesityigGLP-1 drugsduct Zepbound (tirzepatide) can help patients overcome obstructive sleep apnea (OSA), a condition that disrupts breathing during sleep and has been diagnosed in 20 million in the United States.

The phase 3 studies, both a year long, demonstrated thElipLillyts taking tirzepatide hZepbound 3tirzepatideep apnea events per hour thanobstructive sleep apnea (OSA)s—one for patients using continuous positive airway pressure (CPAP) and the other without—met all primary and secondary endpoints.

All patients in the studies were obese and had moderate-to-severe OSA. Thtirzepatideeived a 10 mg or 15 sleep apnean of tirzepatide saw a median reduction in their apnea-hypopnea index (API) of up to 63%, the company said. The index measures the number of times a person’s breathing shows a restricted or complete block of airflow per hour and is the primary tool in evaluating the severity of OSA and the effectiveness of treatments.

In the SURMOUNT-OSA Study 1, which evaluated the effectiveness of OSAzepatide among those not using CPAP machines, the Ltirzepatideas associated with a mean reduction from baseline of 27.4 events per hour, compared to 4.8 for placebo. Investigators also recorded an 18.1% mean weight reduction for tirzepatide versus 1.3% for those on placebo.OSA

In the SURMOUNT-OSA Study 2 for patients on CPAP, there was a meantirzepatideof 30.4 events per hour compared to 6.0 foLillycebo. Additionally, the mean weight loss was 20.1% for tirzepatide versus 2.3% for those on placebo.tirzepatide

OSA is characterOSAd by collapses of the upper airway during sleep, which can lead to a decrease in oxygen saturation and waking from sleep. By forcing air into the system, CPAP mtirzepatide keep the airway open. OSA can have serious complications, including high blood pressure, heart disease, stroke, heart failure, atrial fibrillation and type 2 diabetes.

OSAly’s chief of product development, Jeff Emmick, M.D., Ph.D., said in a release that 85% of those with sleep apnea are “undiagnosed and untreated.”OSA heart disease stroke heart failure atrial fibrillation type 2 diabetes

Lillyessing this unmet need head-on is critical, and while there are pharmaceutical treatments for the exsleep apneaepiness associated with OSA, tirzepatide has the potential to be the first pharmaceutical treatment for the underlying disease,” Emmick added.

Lilly released only partial results from the studies and said it will present more data at the American Diabetes Association’s 84th ScientifOSASetirzepatideune 21. The company, which has already received FDA fast-track designation for tirzepatide to treat OSA, will submit the results to regulatory authorities beginning in the middle of this year, it added.

Lillysts at Leerink Partners noted that there are no drugs approved to treat OSA, with standardAmerican Diabetes Association Diabetesg central nervous system stimulants and dopamine/norepinephrine reuptake inhibitors.FDA tirzepatide OSA

"We assume that these data could result in priority review and approval by eaOSA 2025," the analysts wrote. "The acentral nervous system stimulants provdopamine/norepinephrine reuptake inhibitors we note that 70% of OSA patients are obese."

Zepbound, which was approved in November, is Lilly’s obesity therapy which contains the same compound as the company’s type 2OSAabetes drug Mounjaro, which also has been commonly prescribed off label as a weight-lossOSAeatment.

Zepbounddisk’s comparable drugs Wegovy, for wLilly loobesity Ozempic, for type 2 diabetes, are GLP-1 (glucagon-like peptype 2 diabetesnts whMounjaroy’s drugs combine the dual action of GLP-1 and GIP (glucose-dependent insulinotropic polypeptide).

Novo Nordiskthe FDA expanded WegWegovylabel to reduce the risOzempicrdiovatype 2 diabetesart attack and stroke like peptide-1re overweight.Lilly GLP-1 GIP (glucose-dependent insulinotropic polypeptide)

Two months ago, FDAly presentWegovya from a mid-stage trial that demonstrated tirzepatiheart attackal tostroke the fatty liver disease metabolic dysfunction-associated steatohepatitis (MASH).