AstraZeneca-Amgen Tezspire gets USFDA nod for chronic rhinosinusitis with nasal polyps

The approval by the US Food and Drug Administration (FDA) was based on efficacy and safety data from the WAYPOINT Phase III trial, which were presented at the 2025 American Academy of Allergy Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress and simultaneously published in The New England Journal of Medicine. In the trial, Tezspire demonstrated a statistically significant and clinically meaningful reduction in nasal polyp severity, and showed near-elimination of the need for surgery and significant reduction in systemic corticosteroid use vs. placebo.

Dr. Joseph Han, Vice Chair of Department of Otolaryngology - Head and Neck Surgery, Old Dominion University, US, and co-primary investigator in the WAYPOINT trial, said, “Over 320 million lives globally are disrupted by chronic rhinosinusitis with nasal polyps. The FDA approval of Tezspire brings forward a new treatment option that has demonstrated rapid and sustained symptom improvement, nearly eliminating the need for future surgeries and significantly reducing systemic steroid use. By targeting TSLP at the top of the inflammatory cascade, Tezspire offers a novel option for patients who continue to endure the disruption of this disease despite available treatments.”

Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America (AAFA), said, “Chronic rhinosinusitis with nasal polyps is a persistent and often-overlooked disease that can significantly impact daily life, robbing patients of their ability to breathe without congestion and full sense of smell. This approval introduces an innovative treatment option for patients with the potential to help address the ongoing cycle of debilitating symptoms, surgeries and systemic steroid use.”

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca said, “The approval of Tezspire in chronic rhinosinusitis with nasal polyps expands the reach of this innovative treatment option to patients living with an epithelial-driven inflammatory disease beyond severe asthma. Building on the widespread, established use of Tezspire in severe asthma, this exciting milestone now reinforces its unique mechanism of action across both the upper and lower airways and reflects our commitment to transforming care for patients who face the daily burden of chronic respiratory and immune-mediated diseases.”

CRSwNP affects up to approximately 320 million people worldwide and is a complex epithelial-driven inflammatory condition characterised by persistent inflammation and benign polyp growths within the nasal cavity. People living with CRSwNP commonly experience airflow obstruction and symptoms including congestion and an impaired sense of smell. For many patients, current therapies such as systemic and intranasal corticosteroids and repeated sinus surgeries do not offer lasting relief.

The safety profile and tolerability of Tezspire in the WAYPOINT trial was generally consistent with the known profile of the medicine.

The Committee for Medicinal Products for Human Use (CHMP) recently adopted a positive opinion for the approval of Tezspire in the EU for treatment of CRSwNP. Regulatory applications are currently under review in the EU, China, Japan and several other countries.

Tezspire is currently approved for the treatment of severe asthma in the US, EU, Japan and more than 60 countries across the globe.