FDA Approves Tezepelumab for as Add-On Treatment for Chronic Rhinosinusitis With Nasal Polyps

The FDA approved tezepelumab-ekko (Tezspire) for the add-on maintenance of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSWNP) for patients 12 years and older. This marks the first and only biologic approved for this indication that targets thymic stromal lymphopoietin (TSLP).¹

"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," Jay Bradner, MD, executive vice president of research and development at Amgen, said in a news release.¹ "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."

Chronic rhinosinusitis is a chronic inflammatory sinus disease that is diagnosed after 12 weeks or more. It affects approximately 5% to 12% of the global population, according to the Allergy and Asthma Network. It can also be accompanied by nasal polyps, which are small noncancerous growths that line the nasal passages and sinuses. For patients with chronic rhinosinusitis, approximately 25% to 30% also have nasal polyps. Symptoms can include facial pressure or pain, decreased or absent sense of smell, nasal congestion, runny nose, sore throat, postnasal drip, headaches, and pain in the upper teeth. Current treatment includes corticosteroid nasal sprays, fluticasone with an exhalation delivery system, short-course oral corticosteroids, biologics, and surgery.²

The approval was based on data from the phase 3 WAYPOINT (NCT04851964) trial, which evaluated the efficacy and safety of tezepelumab in adults with severe chronic rhinosinusitis with nasal polyposis. Approximately 400 patients were included who received either tezepelumab or the placebo via a subcutaneous injection that lasted 52 weeks. The primary end points included nasal polyp score from baseline to week 52 and reported nasal congestion from baseline to week 52. As for secondary outcomes, investigators included loss of smell, nasal polyp quality of life, nasal polyposis surgery, receiving systemic corticosteroids for nasal polyposis, sinus opacification, nasal polyposis symptom diary total symptom score, and pre-bronchodilator forced expiratory volume in 1 second for patients with comorbid asthma and aspirin-exacerbated respiratory disease.³

A total of 203 patients received tezepelumab, and 205 received the placebo. At week 52, patients who received tezepelumab had significant improvements in nasal polyp score with a reduction of approximately 2.46 compared with 0.39 for the placebo. As for the nasal congestion score, there were reductions of approximately 1.74 and 0.72, respectively. For the key secondary end points, improvements in loss of smell score were -1.26 for the study drug group compared with -0.25 for the placebo, and total symptom score was reduced by 10.39 and 3.5, respectively.^4,5

"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," Joseph Han, MD, FARS, FAAOA, vice chair of the department of otolaryngology–head and neck surgery at Old Dominion University, said in the news release.¹ "By targeting thymic stromal lymphopoietin 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."

READ MORE: Respiratory Resource Center

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REFERENCES

1. FDA approves Tezspire for chronic rhinosinusitis with nasal polyps. News release. Amgen. October 17, 2025. Accessed October 21, 2025. https://www.amgen.com/newsroom/press-releases/2025/10/fda-approves-tezspire-for-chronic-rhinosinusitis-with-nasal-polyps

2. Allergy and Asthma Network. What is chronic rhinosinusitis with nasal polyps (CRSWNP). Accessed October 21, 2025. https://allergyasthmanetwork.org/health-a-z/chronic-rhinosinusitis-with-nasal-polyps-crswnp/

3. Efficacy and safety of tezepelumab in participants with severe chronic rhinosinusitis with nasal polyposis (WAYPOINT). ClinicalTrials.gov identification: NCT04851964. Updated July 20, 2025. Accessed October 21, 2025. https://clinicaltrials.gov/study/NCT04851964

4. Lipworth BJ, Han JK, Desrosiers M, et al. Tezepelumab in Adults with Severe Chronic Rhinosinusitis with Nasal Polyps. N Engl J Med. 2025;392(12):1178-1188. doi:10.1056/NEJMoa2414482

5. Positive results from the Tezspire Phase III WAYPOINT trial highlight rapid and sustained effect in chronic rhinosinusitis with nasal polyps. News release. March 1, 2025. Accessed October 21, 2025. https://www.astrazeneca.com/media-centre/press-releases/2025/positive-results-from-the-tezspire-phase-iii-waypoint-trial-highlight-rapid-and-sustained-effect-in-chronic-rhinosinusitis-with-nasal-polyps.html