AstraZeneca and Amgen’s Tezspire (tezepelumab) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The recommendation is based on results from the WAYPOINT Phase III trial, which 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.

In the trial, Tezspire showed a statistically significant reduction in nasal polyp severity and nasal congestion at week 52 compared with placebo. Nasal Polyp Score (NPS) decreased by −2.08 (95% CI: −2.40, −1.76; p<0.001) and nasal congestion score (NCS) by −1.04 (95% CI: −1.21, −0.87; p<0.001). Patients receiving Tezspire also experienced a near-complete elimination of the need for surgery (98%) and a significant reduction in systemic corticosteroid use (89%).

Dr. Oliver Pfaar, chair of the Section Rhinology and Allergy at University Hospital Marburg and WAYPOINT investigator, said: “Chronic rhinosinusitis with nasal polyps is a challenging condition. For many patients, current therapies don’t offer lasting relief causing a cycle of repeat surgeries and ongoing treatment with oral corticosteroids, which can result in serious side effects. This positive CHMP recommendation is very encouraging and if approved, tezepelumab will provide patients and clinicians in Europe with an important new treatment option that has demonstrated rapid, sustained symptom relief.”

Ruud Dobber, executive vice president and president of AstraZeneca’s BioPharmaceuticals Business Unit, added: “The CHMP recommendation brings us closer to offering Tezspire to patients across the EU who face the daily challenges of this disruptive and difficult-to-treat disease. The unique way Tezspire works means it addresses the multiple drivers of epithelial-driven inflammation associated with chronic rhinosinusitis with nasal polyps. This pivotal milestone builds upon Tezspire’s foundational impact in severe asthma and reinforces our commitment to transforming respiratory care.”

CRSwNP is a chronic inflammatory condition marked by persistent inflammation and benign polyp growths in the nasal cavity, affecting airflow and impairing smell, taste, and sleep. It impacts roughly 320 million people worldwide, with nearly half of European patients remaining uncontrolled despite standard therapies, including corticosteroids and repeated sinus surgeries.

The safety and tolerability of Tezspire in the WAYPOINT trial were consistent with its established profile. Regulatory submissions are ongoing in the US, China, Japan, and other countries. Tezspire is already approved for severe asthma in more than 60 countries.