AstraZeneca's Tezspire Approved in EU for Chronic Rhinosinusitis with Nasal Polyps

AstraZeneca PLC announced that Tezspire (tezepelumab) has been approved in the European Union (EU) as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) who have not adequately responded to standard therapy. The approval is based on the positive results from the WAYPOINT Phase III trial, which demonstrated a statistically significant and clinically meaningful reduction in nasal polyp severity, near-elimination of the need for surgery, and significant reduction in systemic corticosteroid use compared to placebo. The trial results were presented at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress and published in The New England Journal of Medicine. Tezspire, developed in collaboration with Amgen, targets thymic stromal lymphopoietin (TSLP), a key epithelial cytokine involved in inflammation. The approval marks an important step forward in treating CRSwNP, a condition affecting approximately 320 million people worldwide.