WILMINGTON, DE — AstraZeneca and Amgen have received U.S. Food and Drug Administration (FDA) approval for TEZSPIRE® (tezepelumab-ekko) as an add-on maintenance treatment for adults and adolescents aged 12 and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). The medication becomes the first and only biologic targeting thymic stromal lymphopoietin (TSLP) approved for the condition.
The FDA’s decision was based on results from the Phase III WAYPOINT trial, presented at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) and World Allergy Organization (WAO) Joint Congress and published in The New England Journal of Medicine. In the study, TEZSPIRE demonstrated a statistically significant reduction in nasal polyp severity, nearly eliminated the need for surgery, and lowered systemic corticosteroid use compared to placebo.
“Over 320 million lives globally are disrupted by chronic rhinosinusitis with nasal polyps,” said Dr. Joseph Han, Vice Chair of the Department of Otolaryngology – Head and Neck Surgery at Old Dominion University and co-primary investigator in the WAYPOINT trial. “The FDA approval of TEZSPIRE brings forward a new treatment option that has demonstrated rapid and sustained symptom improvement, nearly eliminating the need for future surgeries and significantly reducing systemic steroid use. By targeting TSLP at the top of the inflammatory cascade, TEZSPIRE offers a novel option for patients who continue to endure the disruption of this disease despite available treatments.”
Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America, added, “Chronic rhinosinusitis with nasal polyps is a persistent and often-overlooked disease that can significantly impact daily life, robbing patients of their ability to breathe without congestion and full sense of smell. This approval introduces an innovative treatment option for patients with the potential to help address the ongoing cycle of debilitating symptoms, surgeries and systemic steroid use.”
Ruud Dobber, Executive Vice President of AstraZeneca’s BioPharmaceuticals Business Unit, stated, “Today’s approval of TEZSPIRE in chronic rhinosinusitis with nasal polyps expands the reach of this innovative treatment option to patients living with an epithelial-driven inflammatory disease beyond severe asthma. Building on the widespread, established use of TEZSPIRE in severe asthma, this exciting milestone now reinforces its unique mechanism of action across both the upper and lower airways and reflects our commitment to transforming care for patients who face the daily burden of chronic respiratory and immune-mediated diseases.”
CRSwNP affects an estimated 320 million people globally and is characterized by chronic inflammation and benign polyp growths that obstruct airflow and reduce the sense of smell. Current therapies, including corticosteroids and repeated sinus surgeries, often fail to provide long-term relief.
According to the study, TEZSPIRE’s safety and tolerability were generally consistent with previous findings. The most frequently reported side effects were COVID-19, nasopharyngitis, and upper respiratory tract infections.
The Committee for Medicinal Products for Human Use (CHMP) has also issued a positive opinion recommending approval of TEZSPIRE for CRSwNP in the European Union, with additional regulatory reviews ongoing in China, Japan, and several other markets.
Already approved for severe asthma in more than 60 countries, TEZSPIRE’s expanded indication strengthens AstraZeneca and Amgen’s foothold in treating complex inflammatory and respiratory diseases through targeted biologic therapies.
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