Approval is for add-on maintenance treatment in adults and pediatric patients ages 12 years and older
By Lori Solomon HealthDay Reporter
TUESDAY, Oct. 28, 2025 (HealthDay News) — The U.S. Food and Drug Administration approved Tezspire (tezepelumab-ekko; Amgen) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients ages 12 years and older.
Tezspire is the first and only biologic approved for CRSwNP that targets thymic stromal lymphopoietin.
The approval was based on efficacy and safety data from the WAYPOINT Phase III trial, which showed a statistically significant and clinically meaningful reduction in nasal polyp severity. Additionally, the trial showed near-elimination of the need for surgery and a significant reduction in systemic corticosteroid use versus placebo. The safety and tolerability profile of Tezspire was generally consistent with its established profile in treating severe asthma, with COVID-19, nasopharyngitis, and upper respiratory tract infection seen as the most frequently reported adverse events.
“For people living with CRSwNP, every breath can feel like a struggle, and many endure years of recurring symptoms and surgeries without significant relief,” Jay Bradner, M.D., executive vice president of research and development at Amgen, said in a statement. “The approval of Tezspire represents a meaningful advance, derived from our longstanding focus on complex inflammatory diseases rooted in epithelial biology.”
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