FDA approves Tezspire (tezepelumab) for chronic rhinosinusitis with nasal polyps – Amgen+ AstraZeneca

Amgen and AstraZeneca  announced that the FDA approved Tezspire  (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older. Tezspire is the first and only biologic approved for CRSwNP that targets thymic stromal lymphopoietin (TSLP).

The approval by the 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.

The safety and tolerability profile of Tezspire in the WAYPOINT trial was generally consistent with its established profile in severe asthma. The most frequently reported adverse events in the trial were COVID-19, nasopharyngitis and upper respiratory tract infection.

WAYPOINT was a double-blind, multi-center, randomized, placebo-controlled, parallel group trial designed to evaluate the efficacy and safety of tezepelumab in adults with uncontrolled CRSwNP. Participants received tezepelumab or placebo, administered via subcutaneous injection. The trial also included a post-treatment follow-up period of 12-24 weeks for participants who completed the 52-week treatment period.

The co-primary endpoints of the trial, were change from baseline in total nasal polyp size, measured by the endoscopic total Nasal Polyp Score, and change from baseline in bi-weekly mean nasal congestion, measured by the participant reported Nasal Congestion Score evaluated as part of the daily Nasal Polyposis Symptom Diary. Key secondary endpoints included loss of smell; improvement in disease specific health-related quality of life as measured by SinoNasal Outcome Test (SNOT-22) score; Lund-Mackay score; time to surgery decision and/or systemic corticosteroids for nasal polyposis; time to nasal polyposis surgery decision; time to systemic corticosteroids for nasal polyposis; Nasal Polyposis Symptom Diary total symptom score and, in the population with co-morbid asthma, pre-bronchodilator FEV1 at Week 52.

Regulatory applications are currently under review in Europe, China, Japan and several other countries based on the WAYPOINT trial.

Dr. Joseph Han, Vice Chairman 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.

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.”

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.”

See citation- Lipworth BJ, Han JK et al. Tezepelumab in Adults with Severe Chronic Rhinosinusitis with Nasal Polyps. N Engl J Med. 2025, 392:1178- DOI: 10.1056/NEJMoa2414482. https://www.nejm.org/doi/full/10.1056/NEJMoa2414482