AstraZeneca & Amgen’s Tezspire Recommended For EU Approval In Chronic Rhinosinusitis With Nasal Polyps

AstraZeneca and Amgen announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Tezspire (tezepelumab) for the treatment of adults with chronic rhinosinusitis with nasal polyps (CRSwNP).

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 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."

The recommendation is supported by data from the phase III WAYPOINT trial, presented at the 2025 AAAAI/WAO Joint Congress and published in The New England Journal of Medicine. In the study, Tezspire achieved its co-primary endpoints, showing a statistically significant reduction in both Nasal Polyp Score (NPS) (-2.08; p<0.001) and Nasal Congestion Score (NCS) (-1.04; p<0.001) at week 52 versus placebo.

Tezspire also demonstrated remarkable clinical benefits beyond symptom relief. Trial results showed the drug reduced the need for sinus surgery by 98% and lowered the requirement for systemic corticosteroids by 89% compared to placebo. The safety profile was consistent with previously established data, with no new safety concerns observed.

Ruud Dobber, Executive Vice President and President, BioPharmaceuticals Business Unit, AstraZeneca, said,  “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 affecting an estimated 320 million people worldwide, causing nasal obstruction, loss of smell and taste, and poor sleep quality. Nearly half of European patients remain uncontrolled with existing therapies, highlighting the need for more effective long-term treatment options.

Tezspire is already approved in over 60 countries, including the US, EU, and Japan, for the treatment of severe asthma. Regulatory applications for CRSwNP are also under review in the US, China, Japan, and other markets.