AstraZeneca and Amgen's Tezspire Recommended for EU Approval for Chronic Rhinosinusitis with Nasal Polyps Following Successful Phase III Trial Results

Reuters
Sep 23
AstraZeneca and Amgen's Tezspire Recommended for EU Approval for Chronic Rhinosinusitis with Nasal Polyps Following Successful Phase III Trial Results

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.

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