AstraZeneca's Tezspire gets FDA approval for nasal polyp condition

The U.S. Food and Drug Administration approved Tezspire (tezepelumab) for treating chronic rhinosinusitis with nasal polyps in adults and patients aged 12 years and older, AstraZeneca (NASDAQ: AZN) and Amgen announced.

The approval covers add-on maintenance treatment for patients with inadequately controlled chronic rhinosinusitis with nasal polyps, a condition affecting up to 320 million people worldwide. Tezspire represents the first biologic targeting thymic stromal lymphopoietin to receive FDA approval for this indication.

The FDA decision was based on data from the WAYPOINT Phase III trial, which showed Tezspire reduced nasal polyp severity and decreased the need for surgery and systemic corticosteroid use compared to placebo. Trial results were presented at the 2025 American Academy of Allergy Asthma & Immunology/World Allergy Organization Joint Congress and published in The New England Journal of Medicine.

Chronic rhinosinusitis with nasal polyps involves persistent inflammation and benign polyp growths within the nasal cavity. Patients typically experience airflow obstruction, congestion, and impaired sense of smell. Current treatments including corticosteroids and sinus surgeries often do not provide lasting relief.

The most frequently reported adverse events in the WAYPOINT trial were COVID-19, nasopharyngitis, and upper respiratory tract infection. The safety profile was consistent with the known characteristics of the medicine.

The European Committee for Medicinal Products for Human Use recently adopted a positive opinion for Tezspire approval in the European Union for treating chronic rhinosinusitis with nasal polyps. Regulatory applications remain under review in the EU, China, Japan, and other countries.

Tezspire currently has approval for severe asthma treatment in the U.S., EU, Japan, and more than 60 countries globally.

You May Also Be Interested In

• SpaceX Shares Indicated To Open At $155
• SEALSQ schedules first quantum security satellite launch with SpaceX for Q4 2026
• Barrick releases 2025 sustainability report with safety improvements