HQ Team
October 22, 2025: The European Union approved AstraZeneca Plc and Amgen Inc.’s add-on therapy to treat adults with a chronic inflammatory condition of the nasal passages.
The drug Tezspire, tezepelumab, is an add-on therapy with intranasal corticosteroids for the treatment of severe chronic rhinosinusitis with nasal polyps who have not adequately responded to standard therapy — systemic corticosteroids or surgery.
The approval was based on a positive opinion of the Committee for Medicinal Products for Human Use and was based on positive results from an end-stage trial.
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 versus a placebo,” according to a statement from AstraZeneca.
Side effects
“Chronic rhinosinusitis with nasal polyps is challenging to treat, as it often requires repeat surgeries and ongoing treatment with systemic corticosteroids, both of which can result in serious side effects,” said Dr Oliver Pfaar, Chair of the Section Rhinology and Allergy, ENT-Department, University Hospital Marburg, Philipps-Universität Marburg in Marburg, Germany and investigator in the trial.
Tezepelumab’s approval in the EU meant that clinicians have an innovative new treatment option, he said.
Ruud Dobber, Executive Vice President and President, BioPharmaceuticals Business Unit, AstraZeneca, said: “This approval broadens Tezspire’s benefits beyond severe asthma and reinforces its innovative mechanism of action that targets thymic stromal lymphopoietin, uniquely addressing epithelial-driven inflammation at its source.”
The disease affects approximately 320 million people worldwide and is a complex disease characterised by epithelial-driven inflammation and benign polyp growths within the nasal cavity.
China, Japan review
Nearly half of the patients diagnosed with the disease in Europe remain uncontrolled, and for many patients, current therapies such as systemic corticosteroids and repeated sinus surgeries do not offer lasting relief.
People living with severe chronic rhinosinusitis with nasal polyps commonly experience airflow obstruction and symptoms including congestion and an impaired sense of smell.
Tezspire was recently approved in the US for the add-on maintenance treatment of adult and paediatric patients aged 12 years and older. Regulatory applications are currently under review in China, Japan and several other countries.
The therapy is approved for severe asthma in the US, EU, Japan and more than 60 countries across the globe.
The 2012 Collaboration Agreement between Amgen and AstraZeneca has been amended and updated over time. For Tezspire, both companies continue to share costs and profits equally after payment by AstraZeneca of a mid single-digit inventor royalty to Amgen.
AstraZeneca continues to lead development, and Amgen continues to lead manufacturing.
