FDA Approves Amgen TEZSPIRE for Chronic Rhinosinusitis

The U.S. Food and Drug Administration (FDA) has authorized TEZSPIRE (tezepelumab-ekko) for the add-on maintenance therapy of poorly managed chronic rhinosinusitis with nasal polyps (CRSwNP) in adults and pediatric patients aged 12 years and above, according to a statement released by Amgen and AstraZeneca.

Targeting thymic stromal lymphopoietin (TSLP), TEZSPIRE is the first and only biologic approved for CRSwNP. CRSwNP is a complicated epithelial-driven inflammatory disease that affects up to 320 million individuals globally. It is characterized by benign polyp growths in the nasal cavity and continuous inflammation.

 Airflow blockage and symptoms including congestion and a diminished sense of smell are frequent in people with CRSwNP. Current  cutting-edge  treatments including repeated sinus operations and systemic and intranasal corticosteroids don't provide long-term relief for a lot of people.

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"For people living with CRSwNP, every breath can feel like a struggle, and many endure years of recurring symptoms and surgeries without significant relief. The approval of TEZSPIRE represents a meaningful advance, derived from our longstanding focus on complex inflammatory diseases rooted in epithelial biology," said Jay Bradner, M.D., executive vice president of Research and Development at Amgen.

"This approval is an important step forward for patients who have long needed more durable options that address the root causes of this disease, while establishing the impact of TSLP inhibition beyond asthma."

The FDA's approval was predicated on safety and efficacy findings from the WAYPOINT Phase III trial, which were concurrently published in The New England Journal of Medicine and presented at the 2025 American Academy of Allergy Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress.