FDA

Tezspire now approved for chronic rhinosinusitis with nasal polyps

October 23, 2025

On October 17, 2025, FDA approved Tezspire (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients ≥12 years of age.

Efficacy

Approval of the new indication was based on efficacy and safety data from the Phase 3 WAYPOINT trial (NCT04851964), in which Tezspire demonstrated a statistically significant and clinically meaningful reduction in nasal polyp severity and showed near-elimination of the need for surgery and significant reduction in systemic corticosteroid use compared with placebo.

Safety

The safety and tolerability profile of Tezspire in the WAYPOINT trial was generally consistent with its established profile in severe asthma. The most common adverse reactions (≥3%) were nasopharyngitis, upper respiratory tract infection, epistaxis, pharyngitis, back pain, influenza, injection site reaction, and arthralgia.

Sources:

Tezspire (Tezepelumab-ekko) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761224s006lbl.pdf Revised October 2025. Accessed October 22, 2025.

FDA Approves TEZSPIRE® for Chronic Rhinosinusitis with Nasal Polyps. [News release]. 2025. https://www.amgen.com/newsroom/press-releases/2025/10/fda-approves-tezspire-for-chronic-rhinosinusitis-with-nasal-polyps

Lipworth BJ, et al; WAYPOINT Study Investigators. (2025, March 1). N Engl J Med. Tezepelumab in Adults with Severe Chronic Rhinosinusitis with Nasal Polyps. https://pubmed.ncbi.nlm.nih.gov/40106374/