Tezspire Secures U.S. FDA Approval for Chronic Rhinosinusitis with Nasal Polyps, Expanding Its Reach Beyond Severe Asthma
AstraZeneca and Amgen have announced that their jointly developed biologic, Tezspire (tezepelumab), has received U.S. Food and Drug Administration (FDA) approval for the add-on maintenance treatment of adults and adolescents aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). The approval marks a significant expansion for Tezspire, already well established in severe asthma, and introduces the first and only biologic therapy targeting thymic stromal lymphopoietin (TSLP) to receive approval for CRSwNP — an epithelial-driven inflammatory disease that affects millions globally.
A Major Milestone in Epithelial-Driven Disease Treatment
This FDA approval broadens Tezspire’s therapeutic reach to a second epithelial-driven inflammatory condition, following its success in severe asthma. The decision is based on compelling data from the Phase III WAYPOINT trial, which demonstrated clinically meaningful and statistically significant reductions in nasal polyp size, nasal congestion, and the need for surgical interventions, compared with placebo.
The findings, presented earlier this year at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) and World Allergy Organization (WAO) Joint Congress, were simultaneously published in The New England Journal of Medicine. The results underscored Tezspire’s ability to meaningfully reduce disease burden and improve quality of life for patients with CRSwNP, a condition that frequently leads to recurring surgeries and prolonged systemic corticosteroid use.
Clinical Impact and Expert Perspectives
According to 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, this approval represents a turning point for patients:
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. By targeting TSLP at the top of the inflammatory cascade, Tezspire offers a novel option for patients who continue to endure this disease despite existing therapies.
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 freely and fully experience their sense of smell. This approval introduces an innovative treatment option that could help break the ongoing cycle of symptoms, surgeries, and steroid dependence.
Expanding Tezspire’s Role Across the Airways
Today’s approval of Tezspire in chronic rhinosinusitis with nasal polyps expands the reach of this innovative treatment to patients living with another epithelial-driven inflammatory disease beyond severe asthma. Building on the broad, established use of Tezspire in severe asthma, this milestone reinforces its unique mechanism of action across both the upper and lower airways and reflects our commitment to transforming care for patients burdened by chronic respiratory and immune-mediated diseases.
Understanding Chronic Rhinosinusitis with Nasal Polyps
CRSwNP is a complex inflammatory disorder marked by persistent inflammation of the nasal mucosa and benign polyp growths that obstruct airflow. This chronic condition affects approximately 320 million people worldwide, leading to symptoms such as nasal blockage, reduced sense of smell, facial pain, and poor sleep quality.
For many, existing treatment options — including systemic or intranasal corticosteroids and repeated sinus surgeries — fail to deliver lasting relief. The disease is increasingly understood as epithelial-driven, with TSLP playing a central role in the inflammatory cascade that sustains the disease process.
The WAYPOINT Phase III Trial
The WAYPOINT trial was a randomized, double-blind, placebo-controlled, multi-centre study designed to evaluate the safety and efficacy of Tezspire in adults with inadequately controlled CRSwNP. Participants received either tezepelumab or placebo via subcutaneous injection over a 52-week treatment period, followed by a post-treatment observation period of up to 24 weeks.
The trial’s co-primary endpoints included changes in total nasal polyp size (measured by endoscopic total Nasal Polyp Score) and nasal congestion severity (assessed via patient-reported daily symptom diaries). Secondary endpoints captured outcomes such as loss of smell, disease-specific quality of life (via the Sino-Nasal Outcome Test or SNOT-22), time to surgical decision, and systemic corticosteroid use.
Tezspire achieved robust results across all major measures — showing rapid, sustained improvements and significant reductions in surgical necessity and systemic steroid dependency. Its safety profile was consistent with prior clinical experience, with the most common adverse events being COVID-19 infection, nasopharyngitis, and upper respiratory tract infection.
Mechanism of Action: Targeting TSLP at the Top of Inflammation
Tezepelumab is a first-in-class human monoclonal antibody that inhibits thymic stromal lymphopoietin (TSLP) — an epithelial cytokine that sits at the top of multiple inflammatory pathways driving allergic, eosinophilic, and epithelial inflammation. By blocking TSLP, Tezspire interrupts the inflammatory cascade at its source, offering a broader mechanism than biologics targeting downstream mediators such as IL-4, IL-5, or IL-13.
TSLP is produced by epithelial cells in response to triggers like allergens, viruses, and pollutants, and its elevated expression correlates with disease severity in asthma, CRSwNP, chronic obstructive pulmonary disease (COPD), and eosinophilic esophagitis (EoE).
Tezspire is currently available in single-use pre-filled syringes and auto-injectors for self-administration, making it convenient for long-term disease management. Since its 2021 approval for severe asthma, over 100,000 patients have been treated globally.
Global Regulatory Path and Ongoing Studies
In addition to the new U.S. approval, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently issued a positive opinion for Tezspire in CRSwNP. Regulatory submissions are also underway in China, Japan, and several other countries, signaling a broad international rollout in the coming months.
Beyond CRSwNP, Tezspire is being evaluated in Phase III trials for COPD and EoE, and has already received Orphan Drug Designation from the FDA for EoE.
AstraZeneca–Amgen Collaboration
Under a 2012 collaboration agreement, AstraZeneca and Amgen share costs and profits equally for Tezspire, with AstraZeneca leading development and Amgen leading manufacturing. In the U.S., both companies co-commercialize the therapy, with Amgen recording product sales and AstraZeneca recording its share as collaboration revenue.
A Continuing Legacy in Respiratory and Immunology Innovation
AstraZeneca’s Respiratory & Immunology division remains a key growth engine for the company, leveraging a 50-year legacy in respiratory science. With a diverse pipeline spanning biologics, inhaled medicines, and novel immunomodulators, AstraZeneca aims to eliminate asthma attacks, reduce COPD mortality, and achieve remission in immune-mediated diseases.
The approval of Tezspire for CRSwNP exemplifies this mission — expanding the treatment’s impact beyond asthma and offering new hope for millions struggling with chronic, inflammatory airway diseases.
In essence, Tezspire’s U.S. approval for CRSwNP not only marks a landmark achievement in respiratory medicine but also underscores AstraZeneca and Amgen’s shared commitment to advancing epithelial biology and transforming care across the spectrum of chronic inflammatory diseases.
