Amgen (AMGN) and AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved TEZSPIRE (tezepelumab-ekko) as an add-on maintenance treatment for inadequately controlled chronic rhinosinusitis with nasal polyps or CRSwNP in adults and pediatric patients aged 12 years and older. TEZSPIRE is now the first and only biologic approved for CRSwNP that targets thymic stromal lymphopoietin (TSLP).
The approval expands TEZSPIRE's indication to a second disease characterized by epithelial-driven inflammation.
CRSwNP affects approximately 320 million people globally. It is a complex inflammatory condition marked by persistent inflammation and benign polyp growths within the nasal cavity. Patients often suffer from airflow obstruction, nasal congestion, and a reduced sense of smell. For many, existing treatments—such as systemic and intranasal corticosteroids or repeated sinus surgeries—fail to provide lasting relief.
Regulatory applications for TEZSPIRE in CRSwNP are currently under review in Europe, China, Japan, and several other countries, based on data from the WAYPOINT trial.
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