Approval is for add-on maintenance treatment in adults and pediatric patients ages 12 years and older<\/p>\n<\/h3>\n
By Lori Solomon HealthDay Reporter<\/b>
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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.<\/p>\n
Tezspire is the first and only biologic approved for CRSwNP that targets thymic stromal lymphopoietin.<\/p>\n
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.<\/p>\n
“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.” <\/p>\n