FDA APPROVES TEZSPIRE® FOR CHRONIC RHINOSINUSITIS WITH NASAL POLYPS

Rhea-AI Summary

Amgen (NASDAQ:AMGN) and AstraZeneca announced FDA approval on October 17, 2025 of TEZSPIRE (tezepelumab-ekko) for add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in patients aged 12 years and older. TEZSPIRE is the first biologic for CRSwNP that targets thymic stromal lymphopoietin (TSLP). Approval was supported by the WAYPOINT Phase III trial, which showed a statistically significant reduction in nasal polyp severity, near-elimination of the need for surgery, and significant reduction in systemic corticosteroid use versus placebo. Safety was described as generally consistent with the drug's established severe asthma profile. Regulatory applications are under review in Europe, China, Japan and other countries.

Positive

• FDA approval for CRSwNP granted on October 17, 2025
• Indication expanded to patients aged 12 years and older
• First TSLP-targeting biologic approved for CRSwNP
• WAYPOINT Phase III showed near-elimination of surgery need versus placebo
• WAYPOINT Phase III showed significant reduction in systemic corticosteroid use

Negative

• Most frequent adverse events included COVID-19, nasopharyngitis, upper respiratory infection
• Hypersensitivity reactions observed; postmarketing anaphylaxis reported
• Live attenuated vaccines should be avoided while receiving TEZSPIRE
• No available data on TEZSPIRE use in pregnant women; third-trimester transfer noted

Insights

Clinical-commercial strategist

FDA approval of TEZSPIRE for CRSwNP extends its clinical reach and creates a new biologic option that reduced surgeries and steroid use in Phase III data.

By securing an additional FDA indication on Oct. 17, 2025, TEZSPIRE becomes the first biologic for chronic rhinosinusitis with nasal polyps that targets TSLP, converting a therapy previously indicated for severe asthma into a treatment for a second epithelial-driven inflammatory disease. The regulatory decision rests on the WAYPOINT Phase III trial and NEJM publication showing a statistically significant reduction in polyp severity, near-elimination of the need for surgery, and significant reduction in systemic corticosteroid use versus placebo.

Clinical uptake and commercial impact will depend on real-world prescribing patterns, payer coverage, and patient identification; these factors carry uncertainty since the release provides no cost, utilization, or label-restricted population details. Safety appeared consistent with the existing asthma profile, with common adverse events listed as COVID-19, nasopharyngitis and upper respiratory infection.

Watch regulatory decisions in Europe, China and Japan and adoption metrics over the next 6–24 months, plus any payer policy statements and real-world data on surgery avoidance and steroid-sparing durability reported after broader use.

Approval Broadens Indication for TEZSPIRE to a Second Disease Characterized by Epithelial-Driven Inflammation

THOUSAND OAKS, Calif., Oct. 17, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) approved TEZSPIRE^® (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older. TEZSPIRE is the first and only biologic approved for CRSwNP that targets thymic stromal lymphopoietin (TSLP).

CRSwNP affects up to approximately 320 million people worldwide and is a complex epithelial-driven inflammatory condition characterized by persistent inflammation and benign polyp growths within the nasal cavity.^1-5 People living with CRSwNP commonly experience airflow obstruction and symptoms including congestion and an impaired sense of smell.^1-5 For many patients, current therapies such as systemic and intranasal corticosteroids and repeated sinus surgeries do not offer lasting relief.³

"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 approval by the Food and Drug Administration (FDA) was based on efficacy and safety data from the WAYPOINT Phase III trial, which were presented at the 2025 American Academy of Allergy Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress and simultaneously published in The New England Journal of Medicine.^6,7 In the trial, TEZSPIRE demonstrated a statistically significant and clinically meaningful reduction in nasal polyp severity and showed near-elimination of the need for surgery and significant reduction in systemic corticosteroid use vs. 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 of 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 profile of TEZSPIRE in the WAYPOINT trial was generally consistent with its established profile in severe asthma.⁶ The most frequently reported adverse events in the trial were COVID-19, nasopharyngitis and upper respiratory tract infection.⁶  

Regulatory applications are currently under review in Europe, China, Japan and several other countries based on the WAYPOINT trial.

TEZSPIRE^® (tezepelumab-ekko) U.S. Indication

TEZSPIRE is indicated for:

• the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.
• the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).

TEZSPIRE^® (tezepelumab-ekko) Important Safety Information 

CONTRAINDICATIONS
Known hypersensitivity to tezepelumab-ekko or excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions
Hypersensitivity reactions were observed in the clinical trials (e.g., rash and allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have been reported. These reactions can occur within hours of administration, but in some instances have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE.

Acute Asthma Symptoms or Deteriorating Disease
TEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus.

Abrupt Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection
It is unknown if TEZSPIRE will influence a patient's response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves.

Live Attenuated Vaccines 
The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE.

ADVERSE REACTIONS 
The most common adverse reactions (incidence ≥ 3%) are:

• Asthma: pharyngitis, arthralgia, and back pain.
• Chronic rhinosinusitis with nasal polyps: nasopharyngitis, upper respiratory tract infection, epistaxis, pharyngitis, back pain, influenza, injection site reaction and arthralgia.

USE IN SPECIFIC POPULATIONS 
There are no available data on TEZSPIRE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.

Please see the full  Prescribing Information  including Patient Information and Instructions for Use.

You may report side effects related to AstraZeneca products by clicking  here .

About TEZSPIRE^® (tezepelumab-ekko)
TEZSPIRE is a first-in-class human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants and other environmental triggers and insults. Specifically, TEZSPIRE targets and blocks TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic and other types of airway inflammation associated with severe asthma.^{8, 9} TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, viruses and other airborne particles.^9,10

Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.^5,8 Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control.^8,9,11

TEZSPIRE is currently approved as a pre-filled, single-use pen and auto-injector for self-administration for the treatment of severe asthma in the U.S., Europe, Japan, and more than 60 countries across the globe,^12-15 and for the treatment of chronic rhinosinusitis with nasal polyps in the U.S. 

Beyond severe asthma and CRSwNP, TEZSPIRE is also in development for other potential indications including chronic obstructive pulmonary disease (COPD) and eosinophilic esophagitis (EoE).^16,17 In October 2021, tezepelumab was granted Orphan Drug Designation by the FDA for the treatment of EoE. 

About Chronic Rhinosinusitis with Nasal Polyps (CRSwNP [nasal polyps]) 
CRSwNP is a complex inflammatory disorder characterized by persistent inflammation of the nasal mucosa accompanied by benign growths, called nasal polyps.^2,3 Nasal polyps can block nasal passages and lead to breathing problems, difficulty in sense of smell, nasal discharge, and other adverse effects on quality of life.^1,4,5

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.¹⁸ Estimates suggest that up to 56% of patients with CRSwNP have comorbid asthma. Thymic stromal lymphopoietin (TSLP) is an epithelial cytokine that has been implicated in shared pathophysiological processes underlying severe asthma and CRSwNP.^19,20

Current treatments for CRSwNP include intranasal and/or systemic corticosteroids, surgery and biologic medication.^3,5,21-26

About the Phase 3 WAYPOINT Trial  
WAYPOINT was a double-blind, multi-center, randomized, placebo-controlled, parallel group trial designed to evaluate the efficacy and safety of tezepelumab in adults with uncontrolled CRSwNP.^6,7,27 Participants received tezepelumab or placebo, administered via subcutaneous injection. The trial also included a post-treatment follow-up period of 12-24 weeks for participants who completed the 52-week treatment period.^6,7,27   

The co-primary endpoints of the trial, were change from baseline in total nasal polyp size, measured by the endoscopic total Nasal Polyp Score, and change from baseline in bi-weekly mean nasal congestion, measured by the participant reported Nasal Congestion Score evaluated as part of the daily Nasal Polyposis Symptom Diary.^6,27 Key secondary endpoints included loss of smell; improvement in disease specific health-related quality of life as measured by SinoNasal Outcome Test (SNOT-22) score; Lund-Mackay score; time to surgery decision and/or systemic corticosteroids for nasal polyposis; time to nasal polyposis surgery decision; time to systemic corticosteroids for nasal polyposis; Nasal Polyposis Symptom Diary total symptom score and, in the population with co-morbid asthma, pre-bronchodilator FEV1 at Week 52.^6,27

About the Amgen and AstraZeneca Collaboration
In 2020, Amgen and AstraZeneca updated the 2012 collaboration agreement for TEZSPIRE. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid-single-digit royalty to Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing. All aspects of the collaboration are under the oversight of joint governing bodies. Under the amended agreement, in North America, Amgen, as the principal, recognizes product sales of TEZSPIRE in the United States, and AstraZeneca, as the principal, recognizes product sales of TEZSPIRE in Canada. AstraZeneca leads commercialization for TEZSPIRE outside North America.

About Amgen 
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world's toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases. 

In 2024, Amgen was named one of the "World's Most Innovative Companies" by Fast Company and one of "America's Best Large Employers" by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average^®, and it is also part of the Nasdaq-100 Index^®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.

For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, YouTube and Threads.

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CONTACT: Amgen, Thousand Oaks
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REFERENCES

1. Stevens WW, et al. Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2016; 4 (4): 565-572.   
2. Bachert C, et al. Phenotypes and Emerging Endotypes of Chronic Rhinosinusitis. J Allergy Clin Immunol Pract. 2016; 4 (4): 621-628.  
3. Del Toro E, Portela J. Nasal Polyps. [Updated 2023 Jul 31]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan. Available from: https://www.ncbi.nlm.nih.gov/books/NBK560746/ [Last accessed: August 2025].  
4. Abdalla S, et al. Prevalence of sinonasal outcome test (SNOT-22) symptoms in patients undergoing surgery for chronic rhinosinusitis in the England and Wales National prospective audit. Clin Otolaryngol. 2012; 37 (4): 276-282.   
5. Chen S, et al. Systematic literature review of the epidemiology and clinical burden of chronic rhinosinusitis with nasal polyposis. Curr Med Res Opin. 2020;36(11):1897-1911.  
6. Lipworth, BJ, Han JK, et al. Tezepelumab in adults with severe, uncontrolled CRSwNP. N Engl J Med. 2025.   
7. Lipworth, BJ, Han JK, et al. Efficacy and safety of tezepelumab in adults with severe chronic rhinosinusitis with nasal polyps: results from the Phase 3 WAYPOINT Study. [Late breaking oral presentation]. Presented at the American Academy of Allergy, Asthma & Immunology/World Allergy Organization Joint Congress 2025 (28 February – 03 March).   
8. Corren J, et al. Tezepelumab in adults with uncontrolled asthma. N Engl J Med. 2017;377:936-946.    
9. Varricchi G, et al. Thymic Stromal Lymphopoietin Isoforms, Inflammatory Disorders, and Cancer. Front Immunol. 2018;9:1595.  
10. Menzies-Gow A, et al. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med. 2021;384:1800-1809.  
11. Li Y, et al. Elevated Expression of IL-33 and TSLP in the Airways of Human Asthmatics In Vivo: A Potential Biomarker of Severe Refractory Disease. J Immunol. 2018; 200: 2253–2262.
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14. AstraZeneca plc. TEZSPIRE approved in Japan for the treatment of severe asthma. Available at: https://www.astrazeneca.com/media-centre/press-releases/2022/tezspire-approved-in-japan-for-severe-asthma.html. [Last accessed: August 2025].     
15. Data on File. AstraZeneca. 2024. REF-251231.
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SOURCE Amgen

FAQ

What did Amgen announce about TEZSPIRE (AMGN) on October 17, 2025?

The FDA approved TEZSPIRE for add-on maintenance treatment of inadequately controlled CRSwNP in patients aged 12+ on October 17, 2025.

What clinical evidence supported the TEZSPIRE (AMGN) FDA approval for CRSwNP?

Approval was based on the WAYPOINT Phase III trial showing reduced polyp severity, near-elimination of surgery need, and reduced systemic steroid use versus placebo.

Which patients are eligible for TEZSPIRE (AMGN) under the new CRSwNP indication?

TEZSPIRE is indicated as add-on maintenance treatment for adult and pediatric patients aged 12 years and older with inadequately controlled CRSwNP.

How does TEZSPIRE (AMGN) work for CRSwNP?

TEZSPIRE targets thymic stromal lymphopoietin (TSLP), an upstream epithelial cytokine implicated in airway and sinus inflammation.

What are the main safety concerns for TEZSPIRE (AMGN) in CRSwNP patients?

Common adverse events included COVID-19, nasopharyngitis, and upper respiratory tract infection; hypersensitivity and postmarketing anaphylaxis were reported.

Are regulatory approvals for TEZSPIRE (AMGN) outside the U.S. pending?

Yes. Regulatory applications are under review in Europe, China, Japan and several other countries based on the WAYPOINT trial.