Eli Lilly and Company’s Zepbound® Approved for Obstructive Sleep Apnoea
Saturday, December 21, 2024
Eli Lilly and Company has announced the approval of Zepbound® (tirzepatide) by the US Food and Drug Administration (FDA) for the treatment of moderate-to-severe obstructive sleep apnoea (OSA) in adults with obesity.
Zepbound, a dual-acting GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) medication, targets excess weight by reducing appetite and caloric intake. It is not suitable for children or individuals with certain medical conditions, including thyroid cancer or severe allergic reactions to tirzepatide.
Common side effects include nausea, diarrhoea, vomiting, abdominal discomfort, and fatigue. Patients should consult their healthcare provider for a full list of possible side effects and safety information.
The SURMOUNT-OSA trials evaluated Zepbound’s efficacy and safety in adults with moderate-to-severe OSA and obesity. The trials included 469 participants across multiple countries, including the US, Germany, China, and Japan.
Participants were randomised to receive Zepbound at a maximum tolerated dose of 10 mg or 15 mg, or a placebo. The primary objective was to assess the reduction in the apnea-hypopnea index (AHI) over 52 weeks.
This marks the first prescription medication available for this condition and represents a significant step in addressing a serious health issue. Zepbound is recommended alongside a reduced-calorie diet and increased physical activity.
OSA is a condition where the upper airway collapses during sleep, causing breathing interruptions or shallow breathing, which can reduce oxygen levels and disrupt sleep. While snoring is a common symptom, fatigue and excessive daytime sleepiness are also indicators. Untreated, OSA can lead to severe health consequences.
Clinical trials have demonstrated Zepbound’s effectiveness in reducing breathing disruptions and promoting weight loss. In the SURMOUNT-OSA phase 3 studies, participants using Zepbound experienced a significant improvement in their condition compared to those receiving a placebo.
After one year of treatment, remission or mild, non-symptomatic OSA was observed in 42% of adults using Zepbound and 50% of those combining Zepbound with PAP therapy, compared to 16% and 14% in the placebo groups, respectively. Additionally, adults treated with Zepbound lost an average of 45 lbs (18%) of body weight, while those combining it with PAP therapy lost 50 lbs (20%).
This approval follows the FDA's earlier decision to authorise Zepbound for obesity treatment in adults with weight-related health conditions in late 2023. To learn more about the medication and its indications, visit the official Zepbound website.
This approval highlights the potential of Zepbound to improve the management of OSA and its associated health challenges, offering new hope for individuals living with this condition.
Source: lilly.com
