FDA Approval of Tezepelumab for Chronic Rhinosinusitis with Nasal Polyps

The FDA has approved tezepelumab-ekko for chronic rhinosinusitis with nasal polyps (CRSwNP) in patients 12 years and older based on WAYPOINT Phase III data.

The drug is the first-in-class to target thymic stromal lymphopoietin (TSLP). This upstream alarmin blockade acts earlier than IL-4/IL-13 or IL-5 biologics and may blunt multiple downstream type 2 pathways.

The WAYPOINT Phase III program demonstrated statistically significant and clinically meaningful reductions in nasal polyp severity and systemic corticosteroid use. The trials also reported marked reductions in the need for surgery and improvements in quality-of-life measures.

Safety and tolerability paralleled tezepelumab’s established profile in severe asthma, with upper respiratory infections and nasopharyngitis among the common adverse events.