US pharmaceutical giant Eli Lilly & Co. (NYSE: LLY) has revealed that the US Food and Drug Administration (FDA) has granted another indication approval for its drug Zepbound (tirzepatide), marking it as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. Zepbound can now be used to improve sleep disorders in adults with moderate-to-severe OSA and obesity, in conjunction with a reduced-calorie diet and increased physical activity.
Phase III SURMOUNT-OSA Study Results Support Approval
The FDA’s approval was based on the positive results from the Phase III SURMOUNT-OSA study, which evaluated the efficacy of Zepbound (10 mg or 15 mg) in treating moderate-to-severe OSA in obese adults, both with and without positive airway pressure (PAP) therapy, over the course of a year. Zepbound demonstrated about five times more effectiveness than placebo in reducing breathing disruptions in adults not on PAP therapy, resulting in 25 fewer breathing disruptions per hour with Zepbound compared to five with placebo. In adults on PAP therapy, Zepbound led to 29 fewer breathing disruptions per hour compared to six with placebo. After one year, 42% of adults on Zepbound and 50% of adults on Zepbound with PAP therapy experienced remission or mild, non-symptomatic OSA, compared to 16% and 14% on placebo, respectively.
Significant Weight Loss and OSA Symptom Improvement
In addition to improved OSA symptoms, adults on Zepbound lost an average of 45 lbs (18%) of their body weight, while those on Zepbound with PAP therapy lost an average of 50 lbs (20%) of their body weight, compared to 4 lbs (2%) and 6 lbs (2%) on placebo, respectively.
Tirzepatide’s Dual Mechanism of Action
Tirzepatide, the active ingredient in Zepbound, is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist. It has been approved in multiple countries, including China and the US, for use under the name Mounjaro for adults with type 2 diabetes to improve glycemic control and as Zepbound for long-term weight management.-Fineline Info & Tech
