AstraZeneca, Amgen’s Tezspire approved in EU as add-on therapy

AstraZeneca (AZN) and Amgen’s (AMGN) Tezspire 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 who have not adequately responded to standard therapy. The approval by the European Commission, EC, follows the positive opinion of the Committee for Medicinal Products for Human Use, CHMP, and was based on positive results from the WAYPOINT Phase III trial, presented at the 2025 American Academy of Allergy, Asthma & Immunology/World Allergy Organization 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