The European Commission approved Tezspire (tezepelumab) as an add-on therapy with intranasal corticosteroids for adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP).


RT’s Three Key Takeaways:

  1. EU Approval – The European Commission approved Tezspire (tezepelumab) as an add-on therapy with intranasal corticosteroids for adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) inadequately controlled by standard treatments.
  2. WAYPOINT Phase III Results – Approval was based on WAYPOINT trial data showing significant reductions in nasal polyp severity and congestion, near-elimination of surgery needs, and reduced systemic corticosteroid use compared with placebo.
  3. Expanded Global Reach – Tezspire’s EU approval broadens its use beyond severe asthma, offering a novel TSLP-targeting option for CRSwNP patients, with additional regulatory reviews ongoing in China, Japan, and other countries.


AstraZeneca and Amgen’s Tezspire (tezepelumab) has been approved in the European Union (EU) as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) who have not adequately responded to standard therapy (systemic corticosteroids and/or surgery).

The authorization follows Tezspire’s approval in the United States last week for chronic rhinosinusitis with nasal polyps (CRSwNP) in patients aged 12 and older.

This approval by the European Commission (EC) follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) and was based on positive results from the WAYPOINT Phase III trial, presented at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress and simultaneously published in The New England Journal of Medicine​.1-3 In the 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 vs. placebo.2,3

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 WAYPOINT trial, said: “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. Tezepelumab’s approval in the EU means clinicians have an innovative new treatment option that has shown a clinically meaningful and significant reduction in nasal polyp size, symptom severity and the need for surgery and systemic corticosteroid use compared to placebo.”

Ruud Dobber, Executive Vice President and President, BioPharmaceuticals Business Unit, AstraZeneca, said: “In Europe, we know that nearly half of patients with chronic rhinosinusitis with nasal polyps remain uncontrolled despite treatment with standard of care, which is why today’s approval of Tezspire is such an important step forward in this challenging disease. This approval broadens Tezspire’s benefits beyond severe asthma and reinforces Tezspire’s innovative mechanism of action that targets thymic stromal lymphopoietin (TSLP), uniquely addressing epithelial-driven inflammation at its source.” 

CRSwNP affects approximately 320 million people worldwide and is a complex disease characterised by epithelial-driven inflammation and benign polyp growths within the nasal cavity.4,5 Nearly half of the patients diagnosed with CRSwNP in Europe remain uncontrolled, and for many patients, current therapies such as systemic corticosteroids and repeated sinus surgeries do not offer lasting relief.5,6 People living with CRSwNP commonly experience airflow obstruction and symptoms including congestion and an impaired sense of smell.5,7-9

The safety profile and tolerability of Tezspire in the WAYPOINT trial was generally consistent with the known profile of the medicine. The most frequently reported adverse events in the trial were COVID-19, nasopharyngitis and upper respiratory tract infection.2

Tezspire was recently approved in the US for the add-on maintenance treatment of adult and paediatric patients aged 12 years and older with inadequately controlled CRSwNP,10 and regulatory applications are currently under review in China, Japan and several other countries. Tezspire is also approved for severe asthma in the US, EU, Japan and more than 60 countries across the globe.10-12


Image: Amgen, AZ via PRnewswire
References: https://www.astrazeneca.com/media-centre/press-releases/2025/tezspire-approved-in-eu-for-crswnp.html