AstraZeneca and Amgen's Tezspire Recommended for EU Approval for Chronic Rhinosinusitis with Nasal Polyps Following Successful Phase III Trial Results
AstraZeneca and Amgen's Tezspire has been recommended for EU approval for chronic rhinosinusitis with nasal polyps following successful Phase III trial results. The WAYPOINT trial showed Tezspire effectively reduces nasal polyp severity and congestion, decreases surgery needs, and lowers systemic corticosteroid use compared to placebo. AstraZeneca will manage sales outside the US, while both companies will commercialize Tezspire in the US.
AstraZeneca plc has announced that Tezspire (tezepelumab), developed in collaboration with Amgen, has been recommended for approval in the European Union by the Committee for Medicinal Products for Human Use (CHMP) for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). This recommendation is based on the results of the WAYPOINT Phase III trial, which demonstrated Tezspire’s efficacy in reducing nasal polyp severity and nasal congestion, significantly decreasing the need for surgery, and lowering the use of systemic corticosteroids compared to placebo. AstraZeneca and Amgen will jointly commercialize Tezspire in the US, while AstraZeneca will manage product sales outside the US. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. AstraZeneca plc published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001654954-25-010967), on September 22, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT) Original Document: here
