FDA Approves TEZSPIRE for Chronic Rhinosinusitis With Nasal Polyps

Reuters
2025/10/18
FDA Approves TEZSPIRE for Chronic Rhinosinusitis With Nasal Polyps

Amgen Inc. and AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved TEZSPIRE® (tezepelumab-ekko) as an add-on maintenance treatment for inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adults and pediatric patients aged 12 years and older. TEZSPIRE is now the first and only biologic approved for CRSwNP that targets thymic stromal lymphopoietin $(TSLP)$. This approval was based on positive results from the Phase III WAYPOINT trial, which demonstrated significant reductions in nasal polyp severity, a near-elimination of the need for surgery, and reduced systemic corticosteroid use compared to placebo. The approval broadens TEZSPIRE's indication to a second disease characterized by epithelial-driven inflammation.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Amgen Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: LA00039) on October 17, 2025, and is solely responsible for the information contained therein.

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