Sleep apnea may very well be the subsequent new indication for an Eli Lilly drug that’s already a blockbuster vendor in metabolic indications. The pharmaceutical large has preliminary Part 3 knowledge exhibiting that therapy with the drug decreased the respiratory interruptions attribute of the frequent sleep problem.
With the constructive knowledge in hand, Lilly mentioned it’s now planning for regulatory submissions searching for to broaden the label of tirzepatide, which is marketed as Mounjaro for sort 2 diabetes and as Zepbound for weight administration. These submissions are anticipated in the course of this 12 months.
Obstructive sleep apnea (OSA) is the collapse or partial collapse of the higher airway, which interrupts respiratory whereas an individual sleeps. This will result in hypopnea, which is decreased respiratory that results in inadequate oxygen consumption, or apnea, a short lived cessation of respiratory. There aren’t any FDA-approved medicine for the situation, which is often managed by medical gadgets. A steady constructive airway strain (CPAP) machine and masks gives fixed airflow to maintain the airway open.
Tirzepatide is a peptide designed to bind to 2 receptors, GLP-1 and GIP. Activating these receptors regulates blood sugar, which supported the once-weekly injectable drug’s preliminary approval in sort 2 diabetes. However this mechanism additionally contributes to feeling full so sufferers eat much less. Final fall, the FDA accredited tirzepatide for continual weight administration. Weight problems is a threat issue for sleep apnea. Lilly’s OSA Part 3 program got down to see if tirzepatide might additionally tackle sleep apnea.
OSA severity is measured in keeping with a ranking scale referred to as the apnea-hypopnea index (AHI). On this scale, an AHI ranking of 30 (30 or extra respiratory episodes per hour) is taken into account extreme. Lilly evaluated tirzepatide’s impact on sleep apnea in two 52-week placebo-controlled Part 3 research enrolling non-diabetic sufferers who have been overweight. The principle purpose in each research was to measure the change in AHI ranking from baseline. The 2 secondary targets have been measuring % adjustments from baseline in AHI and physique weight.
Within the first trial, which enrolled adults who weren’t receiving CPAP remedy, tirzepatide therapy led to a median AHI discount of 27.4 occasions per hour from baseline, Lilly reported. By comparability, the common discount within the placebo arm was 4.8 occasions per hour. The % change in AHI from baseline was a 55% discount for the tirzepatide group versus 5 % for the placebo arm. On weight discount, the tirzepatide group misplaced a median 18.1% of weight in comparison with 1.3% within the placebo arm.
The second Part 3 research enrolled adults who have been receiving CPAP remedy and deliberate to proceed it. At 52 weeks, the research drug group confirmed a median discount of 30.4 AHI occasions per hour in comparison with 6.0 occasions per hour for the placebo group. That interprets to a 62.8% discount for the Lilly drug arm versus 6.4% for placebo. The typical weight discount in tirzepatide-treated members was 20.1% in comparison with 2.3% for the placebo group.
On security, Lilly mentioned unintended effects have been just like earlier checks of the drug. Probably the most generally reported antagonistic occasions within the OSA research have been gastrointestinal-related and included diarrhea, nausea, and vomiting. All are recognized unintended effects of medication on this class. Lilly characterised the unintended effects as delicate to average in severity.
Based on Lilly, an estimated 80 million folks within the U.S. have OSA and greater than 20 million have moderate-to-severe OSA. However most of these instances are undiagnosed and untreated, Jeff Emmick, senior vice chairman, product growth, Lilly, mentioned in a ready assertion.
“Addressing this unmet want head-on is essential, and whereas there are pharmaceutical therapies for the extreme sleepiness related to OSA, tirzepatide has the potential to be the primary pharmaceutical therapy for the underlying illness,” Emmick mentioned.
The Part 3 outcomes will likely be submitted for publication in a peer-reviewed journal, Lilly mentioned. The corporate will even current detailed outcomes on June 21 through the scientific periods assembly of the American Diabetes Affiliation.
Tirzepatide gross sales below the Mounjaro identify accounted for $5.1 billion in income in 2023. Zepbound was accredited for continual weight administration final November. Lilly reported $175.8 million in fourth quarter 2023 gross sales for this indication. In a be aware despatched to traders, Leerink Companions analyst David Risinger mentioned that whereas there aren’t any medicine particularly accredited to deal with OSA, commonplace of care pharmaceutical interventions embrace medicine that promote wakefulness, corresponding to central nervous system stimulants and dopamine/norepinephrine reuptake inhibitors. The dearth of an OSA-specific drug might result in an FDA precedence evaluate for tirzepatide and potential approval in early 2025, Risinger mentioned.
“The addition of OSA to the label might present a significant entry level for entry, and we be aware roughly 70% of OSA sufferers are overweight,” he mentioned.