Amgen and AstraZeneca have announced that the U.S. Food and Drug Administration (FDA) has approved TEZSPIRE® (tezepelumab-ekko) as an add-on maintenance treatment for adults and adolescents (aged 12 years and older) with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). TEZSPIRE is now the first and only biologic therapy approved for CRSwNP that targets thymic stromal lymphopoietin (TSLP)—a key epithelial cytokine involved at the start of the inflammatory cascade.
CRSwNP is a chronic, inflammatory, epithelial-driven condition affecting nearly 320 million people globally. It is characterized by persistent inflammation and benign nasal polyp growths, leading to nasal obstruction, congestion, and loss of smell. For many patients, existing treatments—such as systemic or intranasal corticosteroids and repeated sinus surgeries—fail to provide lasting relief.
“For people living with CRSwNP, every breath can feel like a struggle, and many endure years of recurring symptoms and surgeries without significant relief. The approval of TEZSPIRE represents a meaningful advance, derived from our longstanding focus on complex inflammatory diseases rooted in epithelial biology,” said Jay Bradner, M.D., Executive Vice President of Research and Development at Amgen. “This approval is an important step forward for patients who have long needed more durable options that address the root causes of this disease, while establishing the impact of TSLP inhibition beyond asthma.”
The FDA’s decision was supported by positive efficacy and safety data from the Phase III WAYPOINT trial, presented at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress and published in The New England Journal of Medicine. In the trial, TEZSPIRE achieved statistically significant and clinically meaningful reductions in nasal polyp severity, substantially reduced 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. 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,” said Dr. Joseph Han, Vice Chair, Department of Otolaryngology – Head and Neck Surgery, Old Dominion University, and co-primary investigator of the WAYPOINT trial. “By targeting thymic stromal lymphopoietin (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.”
“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,” said Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America (AAFA). “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.”
The safety and tolerability of TEZSPIRE in the WAYPOINT trial were consistent with its established safety profile in severe asthma. The most common adverse events were COVID-19, nasopharyngitis, and upper respiratory tract infection.
Regulatory applications for TEZSPIRE in CRSwNP are currently under review in Europe, China, Japan, and several other countries, based on the WAYPOINT data.
TEZSPIRE® (tezepelumab-ekko) U.S. Indication:
Add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
(Not indicated for the relief of acute bronchospasm or status asthmaticus.)
Add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
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