FDA Approval Adds Tezepelumab to CRSwNP Treatment Landscape

The United States Food and Drug Administation (FDA) has approved tezepelumab-ekko (Amgen, AstraZeneca) 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.1,2 The new approval adds to the tezepelumab’s (Tezspire) current indications for severe asthma in patients aged at least 12 years.

“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,” Joseph Han, MD, Vice Chair of Department of Otolaryngology - Head and Neck Surgery, Old Dominion University, said in a statement.1

With the new approval, tezepelumab joins previously approved biologics dupilumab, mepolizumab, and omalizumab in the CRSwNP treatment landscape, although tezepelumab is the first thymic stromal lymphopoietin (TSLP)-targeting biologic approved in the field.

The therapy’s BLA submission was supported by positive data from the phase 3 randomized WAYPOINT trial, on which Han served as co-primary investigator. Findings from WAYPOINT were presented at the 2025 American Academy of Allergy, Asthma, & Immunology (AAAAI) annual meeting in San Diego in March.

“What's great about tezepelumab showing a very effective treatment for nasal polyp [is that]… we have one additional option that we can use. I think the choice of which biologic we pick really should be patient dependent on what we're trying to target,” Han told HCPLive while onsite at the AAAAI meeting. “In a phase 3 study everything is well controlled to make sure that you get really clean data but a real world study would be helpful because we know in the real world life gets messy.”

The trial demonstrated that participants on tezepelumab had a significantly improved total nasal polyp (least squares mean difference, 2.101; 95% CI, 2.414 – 1.788; P <.0001) and mean nasal congestion score (mean difference, 1.088; 95% CI, 1.261 – 0.915; P <.0001) compared with placebo. At week 52, tezepelumab also brought significant improvements in loss of smell, SNOT-22, Lund-Mackey score, and total symptom score (P <.0001).3

Tezepelumab also reduced the need for nasal polyp surgery or systemic corticosteroid treatment by 92% compared with placebo (hazard ratio, 0.08; 95% CI, 0.03 – 0.17). Only 1 patient in the treatment arm required surgery, compared with > 40 patients in the placebo arm.3

“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,” Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America (AAFA), added.1

References

1. FDA Approves Tezspire® For Chronic Rhinosinusitis With Nasal Polyps. News release. Amgen. October 17, 2025. https://www.prnewswire.com/news-releases/fda-approves-tezspire-for-chronic-rhinosinusitis-with-nasal-polyps-302587969.html

2. TEZSPIRE approved in the US for chronic rhinosinusitis with nasal polyps. News release. AstraZeneca. October 17, 2025. https://www.astrazeneca-us.com/media/press-releases/2025/TEZSPIRE-approved-in-the-US-for-chronic-rhinosinusitis-with-nasal-polyps.html

3. Han, J, Lipworth, B, Desrosiers, M, et al. Efficacy And Safety Of Tezepelumab In Adults With Severe Chronic Rhinosinusitis With Nasal Polyps: Results From The Phase 3 WAYPOINT Study. J Allergy Clin Immunol. Late-breaker presented at the 2025 AAAAI annual meeting in San Diego from February 28 to March 3.