US FDA Approves Tezspire for Chronic Rhinosinusitis with Nasal Polyps

AstraZeneca and Amgen's Tezspire (tezepelumab) has been approved by the US FDA for the add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in patients aged 12 years and older. This approval is based on the Phase III WAYPOINT trial, which demonstrated significant reductions in nasal polyp severity, near-elimination of the need for surgery, and reduced systemic corticosteroid use. CRSwNP affects approximately 320 million people globally and is characterized by persistent inflammation and nasal polyp growths. Tezspire is the first biologic targeting thymic stromal lymphopoietin (TSLP) approved for CRSwNP. The safety profile was consistent with previous studies, with common adverse events being COVID-19, nasopharyngitis, and upper respiratory tract infections. Regulatory applications are also under review in the EU, China, and Japan.