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FDA Approves TEZSPIRE® for Chronic Rhinosinusitis with Nasal Polyps

On October 17, 2025, Amgen and AstraZeneca jointly announced a groundbreaking advancement in the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). The United States Food and Drug Administration (FDA) has approved TEZSPIRE® (tezepelumab-ekko) as an add-on maintenance therapy for patients aged 12 and older suffering from this persistent condition, which affects approximately 320 million individuals globally. This monumental approval signifies a new approach in managing a disorder that is often inadequately controlled by existing treatments.

Understanding Chronic Rhinosinusitis with Nasal Polyps

Chronic rhinosinusitis with nasal polyps is characterized by ongoing inflammation and the development of benign growths in the nasal cavity. Common symptoms include significant nasal congestion, reduced sense of smell, and difficulty breathing—conditions that can severely impact an individual's quality of life. Current treatment options, which often include systemic corticosteroids and surgical interventions, frequently fall short of providing lasting relief for patients.

Dr. Jay Bradner, executive vice president of Research and Development at Amgen, emphasized the significance of TEZSPIRE’s introduction, stating that for individuals battling CRSwNP, even the smallest breath can become a struggle. The innovation behind TEZSPIRE is its mechanism of action, targeting thymic stromal lymphopoietin (TSLP), a key player in the inflammatory pathways that contribute to the condition.

Clinical Trial Insights

The FDA's decision was supported by data from the WAYPOINT Phase III trial, presented during the 2025 American Academy of Allergy Asthma Immunology/World Allergy Organization Joint Congress. In this study, TEZSPIRE demonstrated a clinically significant reduction in nasal polyp severity while nearly eliminating the necessity for surgery and substantially decreasing systemic corticosteroid usage compared to a placebo. This suggests TEZSPIRE not only alleviates symptoms but also addresses the underlying inflammatory processes of CRSwNP—one of the first biologics to do so.

As Dr. Joseph Han, co-primary investigator of the WAYPOINT trial, noted, this approval delivers a new treatment alternative for CRSwNP patients, targeting the root cause of inflammation rather than merely alleviating symptoms.

Broader Implications for Allergy Patients

The approval of TEZSPIRE opens up new treatment possibilities for millions of people, potentially mitigating the cycle of recurrent symptoms, surgeries, and corticosteroid reliance. Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America, remarked on the life-altering effects that chronic rhinosinusitis with nasal polyps can have, asserting that this new treatment option could mean a dramatic improvement in patient outcomes.

Importantly, the safety profile of TEZSPIRE in the WAYPOINT trial was consistent with previously established data in severe asthma. Common side effects reported included COVID-19, nasal infections, and nasopharyngitis, but no unexpected severe risks were identified.

Future Prospects

With regulatory applications also under consideration in Europe, China, Japan, and various other countries, TEZSPIRE holds promise as a foundational treatment not merely for CRSwNP but potentially for other indications such as chronic obstructive pulmonary disease (COPD) and eosinophilic esophagitis. The innovative approach behind TEZSPIRE signifies a turning point in directing biologic therapies toward conditions plagued by epithelial-driven inflammation, paving the way for more comprehensive and effective patient care.

The approval of TEZSPIRE represents a significant milestone for both healthcare providers and patients alike, adding much-needed hope for individuals facing the burdens of chronic rhinosinusitis with nasal polyps. This innovative treatment provides a spotlight on the future of biologic therapies targeting complex inflammatory diseases.

In conclusion, TEZSPIRE is not just another medication; it stands as a beacon of hope, revolutionizing the landscape of treatment for chronic rhinosinusitis while improving the quality of life for millions affected by this debilitating condition.