September 22, 2025 – Brussels, Belgium – AstraZeneca and Amgen announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Tezspire (tezepelumab) for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The positive opinion is based on results from the Phase III WAYPOINT trial, which demonstrated that Tezspire significantly reduced nasal polyp severity, improved nasal congestion, and nearly eliminated the need for surgery and systemic corticosteroids compared with placebo.
Science Significance
The recommendation marks a potential breakthrough in the treatment of CRSwNP, a chronic inflammatory disorder characterized by persistent nasal mucosa inflammation and benign polyp growth. Tezspire is a first-in-class human monoclonal antibody that targets thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that drives multiple inflammatory cascades. By inhibiting TSLP, Tezspire addresses the root cause of epithelial-driven inflammation, a mechanism shared by severe asthma and CRSwNP. The WAYPOINT trial confirmed that blocking TSLP can provide rapid and sustained relief across symptoms, setting a new scientific benchmark in respiratory and immunological care.
Regulatory Significance
The CHMP’s positive opinion is a critical step toward full European Commission (EC) approval, which is expected in the coming months. Regulatory submissions are also under review in the United States, China, Japan, and other global markets, indicating a coordinated international effort to bring this therapy to patients worldwide. The EMA’s endorsement highlights the strength of the WAYPOINT trial data and the novelty of Tezspire’s mechanism of action, reinforcing the agency’s commitment to addressing high-burden chronic respiratory conditions.
Business Significance
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For AstraZeneca and Amgen, the CHMP recommendation underscores the commercial potential of Tezspire beyond severe asthma, where it is already approved in over 60 countries. Chronic rhinosinusitis with nasal polyps affects up to 320 million people globally, representing a large, underserved patient population. Expanding Tezspire’s label to CRSwNP opens a multi-billion-dollar market opportunity, strengthens AstraZeneca’s Respiratory & Immunology portfolio, and enhances Amgen’s biologics revenue stream. Under their collaboration agreement, both companies share development costs and profits, with AstraZeneca leading development and Amgen managing U.S. manufacturing and recording U.S. sales.
Patients’ Significance
CRSwNP patients often endure a cycle of repeated surgeries and long-term corticosteroid use, which carries serious side effects and offers limited long-term relief. Results from the WAYPOINT trial showed that Tezspire reduced the need for surgery by 98% and cut corticosteroid use by 89% compared with placebo. Patients also experienced improved airflow, restored sense of smell, and enhanced quality of life as measured by the SinoNasal Outcome Test (SNOT-22). For nearly half of European patients who remain uncontrolled on existing therapies, Tezspire could provide the first truly disease-modifying option.
Policy Significance
The CHMP’s recommendation reflects the EU’s broader policy goals of accelerating access to innovative biologics for chronic inflammatory diseases. By addressing an unmet need and reducing reliance on systemic steroids and surgical interventions, Tezspire has the potential to reduce healthcare costs and resource utilization. Faster approvals for first-in-class treatments like Tezspire also align with the European Commission’s objectives of strengthening patient access to advanced therapies while supporting pharmaceutical innovation.
Transaction Highlights
The CHMP’s positive opinion for Tezspire is supported by robust data from the global Phase III WAYPOINT trial, which demonstrated that the therapy achieved a mean reduction of –2.08 in Nasal Polyp Score (NPS) and a –1.04 reduction in Nasal Congestion Score (NCS) at week 52 versus placebo (p<0.001 for both). These primary endpoints were reinforced by key secondary outcomes, including a 98% reduction in the need for surgical intervention, an 89% decrease in systemic corticosteroid use, and significant improvements in patients’ sense of smell and overall quality of life as measured by the SNOT-22 questionnaire. The safety profile remained consistent with previous clinical studies, with no new safety signals identified. Regulatory submissions for Tezspire in CRSwNP are already underway in the United States, China, Japan, and other key global markets, and the therapy is also being evaluated in Phase III trials for COPD and eosinophilic esophagitis, which could further expand its clinical utility and commercial reach.
Source: AstraZeneca and Amgen Press Release
