AstraZeneca, Amgen’s Tezspire recommended for approval in EU

AstraZeneca (AZN) and Amgen’s (AMGN) Tezspire has been recommended for approval in the European Union, EU, for the treatment of adult patients with chronic rhinosinusitis with nasal polyps, CRSwNP. The Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, based its positive opinion on results from the WAYPOINT Phase III trial, which were 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 WAYPOINT trial, Tezspire demonstrated a statistically significant and clinically meaningful reduction in nasal polyp severity, as measured by the co-primary endpoints; Nasal Polyp Score by -2.08 and nasal congestion by -1.04 at week 52 compared to placebo.1,2 Data also showed Tezspire enabled near-complete elimination of the need for surgery and significantly reduced the need for systemic corticosteroid treatment compared to placebo.