FDA approves tezepelumab for CRSwNP in patients 12 years and up

FDA approves tezepelumab for CRSwNP in patients 12 years and up | Image credit: Contemporary Pediatrics

On October 17, 2025, the FDA approved tezepelumab (Tezspire; AstraZeneca and Amgen) as an add-on maintenance treatment for adults and adolescents aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP), according to a press release from AstraZeneca.¹

The approval was supported by efficacy and safety data from the phase 3 WAYPOINT trial (NCT04851964), which evaluated tezepelumab in patients with severe, uncontrolled CRSwNP compared with placebo.² Tezepelumab is the first and only biologic targeting thymic stromal lymphopoietin (TSLP) to receive FDA approval for this indication.¹

"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," said Joseph Han, MD, FARS, FAAOA, vice chair, Department of Otolaryngology, Head and Neck Surgery, Old Dominion University, in a statement. "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."

Tezepelumab is a human monoclonal antibody that inhibits TSLP, an epithelial cytokine implicated in airway inflammation. By blocking TSLP at the start of the inflammatory cascade, the therapy addresses multiple pathways involved in CRSwNP.

Phase 3 WAYPOINT trial that led to tezepelumab approval

WAYPOINT was a double-blind, randomized, placebo-controlled trial that enrolled 408 adults with physician-diagnosed, symptomatic, severe CRSwNP. Participants were assigned to receive subcutaneous tezepelumab 210 mg or placebo every four weeks for 52 weeks, alongside standard care.²

The coprimary endpoints were changes from baseline in total nasal-polyp score and mean nasal-congestion score at week 52. Key secondary endpoints included measures of smell, disease-related quality of life, radiographic sinus opacification, overall symptom burden, and the need for nasal-polyp surgery or systemic corticosteroid therapy.

What efficacy data led to tezepelumab approval?

In total, 203 patients were assigned to receive tezepelumab and 205 to receive placebo. At week 52, treatment with tezepelumab resulted in statistically significant and clinically meaningful improvements compared with placebo across all major efficacy measures:

• Total nasal-polyp score: Mean difference vs placebo, −2.08 (95% CI, −2.40 to −1.76)
• Mean nasal-congestion score: Mean difference vs placebo, −1.04 (95% CI, −1.21 to −0.87) (P < 0.001 for both scores)
• SNOT-22 total score: Mean difference vs placebo, −27.44 (95% CI, −32.51 to −22.37)
• Lund–Mackay score: Mean difference vs placebo, −5.70 (95% CI, −6.37 to −5.03)
• Total symptom score: Mean difference vs placebo, −6.96 (95% CI, −8.09 to −5.83)
• Need for nasal-polyp surgery: 0.5% with tezepelumab vs 22.0% with placebo (HR, 0.02; 95% CI, 0.00–0.09)
• Use of systemic glucocorticoids: 5.2% with tezepelumab vs 19.3% with placebo (HR, 0.11; 95% CI, 0.04–0.25)

Adverse events were generally consistent with the known safety profile of tezepelumab. The most common events included nasopharyngitis, upper respiratory tract infection, and COVID-19.¹

“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," added Kenneth Mendez, president, CEO, Asthma and Allergy Foundation of America. "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.”

References:

1. Tezspire approved in the US for chronic rhinosinusitis with nasal polyps. AstraZeneca. Press release. October 17, 2025. Accessed October 17, 2025. https://www.astrazeneca.com/media-centre/press-releases/2025/us-fda-approves-tezspire-in-crswnp.html
2. Lipworth BJ, Han JK, Desrosiers M, et al. Tezepelumab in Adults with Severe Chronic Rhinosinusitis with Nasal Polyps. N Engl J Med. doi:10.1056/NEJMoa2414482