AstraZeneca's Tezspire Receives EU Regulatory Recommendation for Chronic Rhinosinusitis with Nasal Polyps
核心洞察
The European Medicines Agency (搜索)'s Committee for Medicinal Products for Human Use (搜索) (CHMP (搜索)) has recommended approval of AstraZeneca and Amgen's Tezspire (tezepelumab) for treating chronic rhinosinusitis with nasal polyps (搜索) in adults.
The WAYPOINT Phase III trial demonstrated significant reductions in nasal polyp severity and congestion, with 98% elimination of surgery need and 89% reduction in systemic corticosteroid use compared to placebo.
This recommendation represents a potential breakthrough for the approximately 320 million people worldwide affected by this chronic inflammatory condition, where nearly half of European patients remain uncontrolled with current therapies.
AstraZeneca and Amgen's Tezspire (tezepelumab) has received a positive recommendation from the European Medicines Agency (搜索)'s Committee for Medicinal Products for Human Use (搜索) (CHMP (搜索)) for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (搜索) (CRSwNP (搜索)). The recommendation brings the first-in-class monoclonal antibody closer to approval for a condition that affects up to 320 million people worldwide.
WAYPOINT Trial Demonstrates Strong Efficacy
The CHMP (搜索)'s positive opinion was based on results from the WAYPOINT Phase III trial, a double-blind, multi-centre, randomised, placebo-controlled study that evaluated tezepelumab's efficacy and safety in adults with severe CRSwNP (搜索). The trial results were presented at the 2025 American Academy of Allergy Asthma & Immunology/World Allergy Organization Joint Congress and simultaneously published in The New England Journal of Medicine.
In the 52-week trial, Tezspire demonstrated statistically significant and clinically meaningful improvements across both co-primary endpoints. The treatment reduced nasal polyp severity, as measured by the Nasal Polyp Score (NPS), by -2.08 (95% CI: -2.40, -1.76; p<0.001) compared to placebo. Additionally, nasal congestion, measured by the participant-reported Nasal Congestion Score, improved by -1.04 (95% CI: -1.21, -0.87; p<0.001) at week 52.
Perhaps most remarkably, the data showed Tezspire enabled near-complete elimination of the need for surgery (98%) and significantly reduced the need for systemic corticosteroid treatment (89%) compared to placebo. These findings address two major treatment challenges in CRSwNP (搜索) management.
Addressing Significant Unmet Medical Need
Chronic rhinosinusitis with nasal polyps (搜索) is a complex inflammatory disorder characterised by persistent inflammation of the nasal mucosa accompanied by benign growths called nasal polyps. These polyps can block nasal passages, leading to breathing problems, difficulty in sense of smell, nasal discharge, facial pain, sleep disturbance and other adverse effects on quality of life.
Nearly half of the patients diagnosed with CRSwNP (搜索) in Europe remain uncontrolled, and for many patients, current therapies such as systemic corticosteroids (搜索) and repeated sinus surgeries do not offer lasting relief. Current treatments include intranasal and/or systemic corticosteroids, surgery and biologics.
"Chronic rhinosinusitis with nasal polyps (搜索) 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 (搜索), which can result in serious side effects," said Dr. Oliver Pfaar, Chair of the Section Rhinology and Allergy, ENT-Department, University Hospital Marburg, Philipps-Universität Marburg in Germany and investigator in the WAYPOINT trial. "This positive CHMP (搜索) 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."
Novel Mechanism of Action
Tezepelumab represents a first-in-class human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (搜索) (TSLP (搜索)), a key epithelial cytokine that sits at the top of multiple inflammatory cascades. TSLP is critical in the initiation and persistence of allergic, eosinophilic and other types of epithelial inflammation associated with severe asthma (搜索), CRSwNP (搜索) and other inflammatory diseases.
Epithelial dysfunction and inflammation are important characteristics of chronic rhinosinusitis and impede the ability of the epithelium to act as a physical and immunological barrier against the external environment. TSLP (搜索) is released by the epithelium in response to environmental triggers, including allergens, viruses and other airborne particles. Across disease states like CRSwNP (搜索), the expression of TSLP is increased and correlates with disease severity.
"The unique way Tezspire works means it addresses the multiple drivers of epithelial-driven inflammation associated with chronic rhinosinusitis with nasal polyps (搜索)," said Ruud Dobber, Executive Vice President and President, BioPharmaceuticals Business Unit, AstraZeneca. "This pivotal milestone builds upon Tezspire's foundational impact in severe asthma (搜索) and reinforces our commitment to transforming respiratory care."
Global Regulatory Progress and Market Position
The safety profile and tolerability of tezepelumab in the WAYPOINT trial were consistent with the known profile of the medicine. Regulatory applications are currently under review in the US, China, Japan and several other countries based on the WAYPOINT trial results.
Tezspire is currently approved for the treatment of severe asthma (搜索) in the US, EU, Japan and more than 60 countries across the globe. Since 2021, over 100,000 patients have been treated with Tezspire for severe asthma. The drug is approved as a single-use pre-filled syringe and auto-injector for self-administration.
Beyond CRSwNP (搜索), Tezspire is also being explored in Phase III trials in chronic obstructive pulmonary disease (搜索) (COPD (搜索)) and eosinophilic esophagitis (搜索) (EoE (搜索)). In October 2021, Tezspire was granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of EoE.
The development of tezepelumab continues under the collaboration between AstraZeneca and Amgen, established through their 2012 Collaboration Agreement. Both companies share costs and profits equally, with AstraZeneca leading development and Amgen leading manufacturing.