FDA Clears Tezspire for Nasal Polyps in Patients 12 and Older

Overview

• The expanded indication authorizes tezepelumab-ekko as add-on maintenance therapy for inadequately controlled chronic rhinosinusitis with nasal polyps in adolescents and adults.
• In late-stage testing, patients had clinically meaningful reductions in polyp size and nasal congestion versus placebo.
• Trial data reported 98% fewer patients requiring nasal polyp surgery and an 88% drop in oral corticosteroid use.
• Tezspire blocks TSLP, an upstream inflammatory cytokine, which Amgen says demonstrates the approach’s versatility beyond asthma.
• The drug enters a market that includes Dupixent, Nucala and Xolair, with one analyst suggesting it might outperform Dupixent for this condition.