THOUSAND OAKS, Calif., October 17, 2025 — In a landmark regulatory decision, the U.S. Food and Drug Administration (FDA) has approved TEZSPIRE® (tezepelumab-ekko) as an add-on maintenance therapy for adults and adolescents aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). The approval, announced jointly by Amgen (NASDAQ: AMGN) and AstraZeneca, marks the first and only biologic targeting thymic stromal lymphopoietin (TSLP) to be cleared for CRSwNP—broadening its use beyond severe asthma.
Science Significance
TEZSPIRE’s approval underscores a paradigm shift in treating epithelial-driven inflammatory diseases.
Unlike other biologics that target downstream mediators of inflammation, TEZSPIRE blocks TSLP, a key epithelial cytokine that triggers multiple immune pathways involved in airway inflammation. By intervening at the top of the inflammatory cascade, TEZSPIRE addresses a common upstream driver shared between asthma and CRSwNP. Chronic rhinosinusitis with nasal polyps affects up to 320 million people globally and is characterized by persistent inflammation and benign growths that cause nasal obstruction, congestion, and loss of smell. Current treatment options—corticosteroids, sinus surgery, and other biologics—often fail to provide lasting relief or prevent recurrence. The Phase III WAYPOINT trial, published in The New England Journal of Medicine and presented at the 2025 AAAAI/WAO Joint Congress, demonstrated that TEZSPIRE significantly reduced nasal polyp size and severity, nearly eliminating the need for surgery while markedly lowering systemic corticosteroid use compared with placebo.
Regulatory Significance
The FDA’s decision was based on robust safety and efficacy data from the pivotal WAYPOINT Phase III trial, which evaluated TEZSPIRE in adults with severe, uncontrolled CRSwNP. This marks TEZSPIRE’s second major U.S. approval, following its 2021 authorization for severe asthma. “This approval represents an important step forward for patients who have long needed durable treatment options that address the root causes of CRSwNP,” said Dr. Jay Bradner, Executive Vice President of R&D at Amgen. “It further validates TSLP inhibition as a foundational approach to chronic inflammatory diseases.” Regulatory applications are currently under review in Europe, Japan, China, and other markets, positioning TEZSPIRE for potential global expansion. The drug’s safety profile in CRSwNP was consistent with its established record in asthma, with the most common adverse events being nasopharyngitis, upper respiratory infections, and mild injection-site reactions.
Business Significance
Advertisement
The TEZSPIRE collaboration between Amgen and AstraZeneca exemplifies the strength of shared innovation in biologics development. Under the amended 2020 agreement, AstraZeneca leads global development, while Amgen oversees manufacturing. Both companies share costs and profits equally, with Amgen recognizing U.S. sales and AstraZeneca commercializing the therapy outside North America. The CRSwNP indication significantly broadens TEZSPIRE’s commercial potential, tapping into a market segment with limited effective biologic therapies and high unmet medical need. Analysts estimate that biologics for upper airway inflammatory conditions could surpass $5 billion in annual sales globally by 2030, with TEZSPIRE well positioned to capture a substantial share. “This milestone establishes TEZSPIRE as a platform therapy across epithelial-driven diseases,” said an AstraZeneca spokesperson, “demonstrating that TSLP inhibition has potential applications beyond asthma—into sinus disease, COPD, and eosinophilic esophagitis.”
Patients’ Significance
For patients living with CRSwNP, each breath can be a daily struggle. Nasal obstruction, facial pain, and loss of smell diminish quality of life, and many endure repeated sinus surgeries without lasting relief. Dr. Joseph Han, Vice Chair of Otolaryngology at Old Dominion University and co-primary investigator of the WAYPOINT trial, emphasized the patient impact: “By targeting TSLP, TEZSPIRE delivers rapid, sustained symptom improvement, reducing future surgeries and the dependence on systemic steroids. This is a transformative advance for patients.” Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America, added, “This approval offers renewed hope for millions who have faced years of chronic congestion and loss of smell, providing a scientifically grounded solution that goes beyond symptomatic management.”
Policy Significance
The approval aligns with the FDA’s broader policy goals of accelerating biologic innovation in chronic inflammatory diseases with unmet needs. TEZSPIRE’s journey reflects the regulatory trend toward mechanism-based approvals, where targeting root immune drivers—rather than organ-specific symptoms—yields broad clinical benefits. The agency’s ongoing collaboration with sponsors like Amgen and AstraZeneca demonstrates regulatory agility in evaluating biologics that straddle multiple disease areas, encouraging further R&D investment in epithelial and immunologic pathways. As biologic approvals expand, payer and access frameworks are also evolving. Early signals suggest that TEZSPIRE’s dual indication profile may strengthen formulary inclusion and reimbursement potential, especially for patients with overlapping asthma and CRSwNP.
Transaction Highlights
Under the Amgen–AstraZeneca collaboration agreement, both companies share global development costs and profits equally, demonstrating a balanced approach to innovation and commercialization. AstraZeneca leads the clinical development, regulatory submissions, and global marketing for TEZSPIRE, ensuring consistent strategy across international markets. Meanwhile, Amgen is responsible for manufacturing, U.S. commercialization, and domestic regulatory coordination, leveraging its biologics production and distribution expertise. The arrangement allows each company to capitalize on its core strengths—AstraZeneca’s global respiratory and immunology portfolio and Amgen’s biologics and manufacturing leadership. Outside North America, AstraZeneca holds exclusive rights for marketing and distribution, while Amgen recognizes U.S. product sales and shares related profits. This partnership structure, governed by a joint global governance framework, streamlines decision-making and lifecycle management, ensuring coordinated execution from research to market expansion. The collaboration model has proven highly effective, with TEZSPIRE now positioned as a multi-indication biologic targeting both severe asthma and chronic rhinosinusitis with nasal polyps, extending its market reach and patient impact worldwide.
Source: Amgen Press Release
