The U.S. Food and Drug Administration today approved Zepbound (tripeptide) for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity. This is a first-of-its-kind drug therapy for OSA and is intended to be used in conjunction with a reduced-calorie diet and increased physical activity.
Today’s approval is a huge step forward for patients with obstructive sleep apnea, said Dr. Sally Seymour, director of the Division of Pulmonology, Allergy, and Critical Care at the FDA.
Obesity disproportionately affects people who have OSA, which is characterized by interruptions in breathing during sleep due to airway blockages. Zepbound addresses this by activating gut hormone receptors to reduce appetite and promote weight loss, which in turn alleviates OSA symptoms.
The approval of Zepbound is derived from two clinical trials comprising 469 adults who did not have type 2 diabetes. Participants took weekly doses of Zepbound or a placebo during the period of 52 weeks. The studies measured the apnea-hypopnea index, measuring interruption of breathing in slumber. Results found that patients treated with Zepbound experienced a significant drop in AHI and weight of patients compared to those treated with placebos. Many individuals showed remission or light OSA.
However, Zepbound has the risk of causing nausea, vomiting, abdominal pain, and reactions at the injection site. It has also been found to be a cause of thyroid C-cell tumors in rats. Whether this applies to human beings is unknown. Contraindicated in those with a personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia syndrome type 2.
Other warnings include pancreatitis, gallbladder disease, hypoglycemia, and renal impairment. Patients should advise healthcare providers of any pre-existing conditions or planned procedures.
The approval of Zepbound brings hope for patients who cannot tolerate standard therapies such as PAP, which may revolutionize the management of OSA in patients with obesity.
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