By: IPP Bureau
Last updated : September 23, 2025 12:35 pm
Tezspire nearly eliminated the need for surgery, reducing surgical intervention by 98 per cent
AstraZeneca and Amgen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Tezspire (tezepelumab) for approval in the European Union for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
The positive opinion is based on results from the pivotal Phase III WAYPOINT trial, which were presented earlier this year at the 2025 American Academy of Allergy Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress and published in The New England Journal of Medicine. In the study, Tezspire demonstrated a statistically significant and clinically meaningful reduction in nasal polyp severity and nasal congestion compared to placebo at 52 weeks. Results showed that treatment with Tezspire reduced the Nasal Polyp Score by -2.08 and improved the Nasal Congestion Score by -1.04, with both outcomes meeting the trial’s co-primary endpoints.
Importantly, Tezspire nearly eliminated the need for surgery, reducing surgical intervention by 98 per cent, and significantly lowered the use of systemic corticosteroids by 89 per cent compared with placebo. The safety and tolerability profile observed in the trial was consistent with the established safety record of the medicine.
Dr. Oliver Pfaar, Chair of the Section Rhinology and Allergy, ENT-Department, University Hospital Marburg, Philipps-Universität Marburg and investigator in the WAYPOINT trial, said: “Chronic rhinosinusitis with nasal polyps is a challenging condition. Many patients do not experience lasting relief from current therapies, resulting in repeated surgeries and ongoing corticosteroid use, which carry the risk of serious side effects. The positive CHMP recommendation is very encouraging. If approved, tezepelumab will provide patients and clinicians across Europe with a much-needed treatment option that has demonstrated rapid and sustained symptom relief.”
Ruud Dobber, Executive Vice President and President, BioPharmaceuticals Business Unit, AstraZeneca, added: “The CHMP recommendation brings us closer to making Tezspire available to patients across the EU who live with the daily burden of this difficult-to-treat disease. Tezspire’s unique mechanism of action targets multiple drivers of epithelial-driven inflammation, reinforcing its potential to transform outcomes in chronic rhinosinusitis with nasal polyps, just as it has in severe asthma.”
CRSwNP is a chronic inflammatory condition characterized by persistent inflammation and the growth of benign nasal polyps that can block airflow and impair the sense of smell, taste and sleep. It is estimated to affect around 320 million people worldwide. Nearly half of patients with CRSwNP in Europe remain uncontrolled despite available therapies, with many requiring repeated use of systemic corticosteroids and sinus surgery, which often fail to provide lasting relief.
Regulatory applications for Tezspire in CRSwNP are currently under review in the United States, China, Japan and several other countries. Tezspire is already approved for the treatment of severe asthma in the US, EU, Japan and more than 60 countries worldwide.