FDA Greenlights TEZSPIRE® for Nasal Polyps: First Biologic to Target TSLP

October 21, 2025

Raziya Begum

Amgen and AstraZeneca announced U.S. Food and Drug Administration (FDA) approval of TEZSPIRE (tezepelumap-ekko) for an add-on maintenance therapy of chronic rhinosinusitis with nasal polyps (CRSwNP) in patients aged ≥12 years. TEZPIRE is the first and only biologic approved for CRSwNP that targets the thymic stromal lymphopoietin (TSLP), addressing inadequately controlled cases of the disease.

CRSwNP affects around 320 million individuals globally and is characterized by chronic nasal inflammation and the development of benign polyps. Common symptoms include impaired smell, airflow obstruction, and congestion. Many patients experience recurring symptoms and only short-term relief from current treatments such as corticosteroids and sinus surgeries. This highlights the need for effective and long-lasting therapies.

This approval was mainly based on results from the WAYPOINT Phase 3 (NCT04851964) clinical study. This trial evaluated the safety and efficacy of TEZSPIRE in patients with severe chronic rhinosinusitis with nasal polyposis. This trial was a multicenter, randomized, double-blinded, placebo-controlled, and parallel-group design. This data was presented at the American Academy of Allergy Asthma & Immunology and published in The New England Journal of Medicine. A total of 400 participants (≥18 years) were enrolled and randomized in a 1:1 ratio to receive either TEZSPIRE or placebo with a follow-up period of 52 weeks.

Results showed that a significant reduction in the severity of nasal polyps was observed in TEZSPIRE compared to the placebo group, including a nasal polyp score of -2.065 (95% CI: -2.389, -1.742; p<0.0001), and a nasal congestion score of -1.028 (95% CI: -1.201, -0.855; p<0.0001). TEZPIRE patients significantly decreased the need for the systemic corticosteroids by 88% (p<0.0001) and subsequent surgery for nasal polyp by 98% (p<0.0001) compared to controls.

Commonly reported adverse reactions (≥3% incidences) were upper respiratory tract infection, COVID-19, back pain, epistaxis, influenza, nasopharyngitis, and injection site reactions.

Dr. Joseph Han, Vice Chair, Département of Otolaryngology, co-primary investigator of the WAYPOINT trial, said, “CRSwNP affects over 320 million people globally, often causing persistent nasal congestion, breathing difficulties, and loss of smell. Most patients suffer from recurring symptoms and require repeated surgery and steroid use with limited relief. TEZSPIRE’s FDA approval marks a significant advancement in treating this disease.”

Dr.Jay Bbradnr, MD, Vice President, R&D, Amgen, emphasized that TEZPIRE’s role in targeting the root causes of CRSwNP by inhibiting TSLP, which is a key driver of inflammation. He noted that this milestone was a meaningful step forward for patients needing more durable and biologic treatment options beyond asthma.

Kenneth Mendez, CEO, Asthma and Allergy Foundation of America (AAFA), reinforced the importance of this approval for those suffering daily from CRSwNP. TEZSPIRE introduces an innovative treatment that may reduce the symptoms and provide lasting relief for millions living with CRSwNP worldwide.

TEZSPIRE is already approved for severe asthma in more than 60 countries, such as Japan, the US, and the EU, with a self-injection option. Regulatory reviews for CRSwNP are currently underway in Japan, Europe, China, and several other countries for potential approval.

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