The US Food and Drug Administration approved tezepelumab (Tezspire) as an add-on maintenance treatment for adult and adolescent patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps. The decision was based on phase 3 WAYPOINT data showing clinically meaningful improvements in nasal polyp size, congestion, and corticosteroid use compared with placebo. The trial also evaluated need for nasal polyp/sinus surgery as a clinical outcome.
In WAYPOINT, tezepelumab demonstrated statistically significant reductions in total nasal polyp score and congestion, nearly eliminating the need for sinus surgery. Patients treated with the biologic experienced substantial symptom improvement and decreased systemic corticosteroid dependence. The safety profile was consistent with previous indications, with the most common adverse events including COVID-19, nasopharyngitis, and upper respiratory tract infection.
Trial note: WAYPOINT enrolled adults, while the US Food and Drug Administration approval covers adults and adolescents (≥12 years).
Standard therapies—such as systemic and intranasal corticosteroids or repeated sinus surgeries—often fail to provide durable relief.
Tezepelumab is a first-in-class human monoclonal antibody that blocks thymic stromal lymphopoietin, an epithelial cytokine that drives allergic and eosinophilic inflammation. By inhibiting thymic stromal lymphopoietin at the top of the inflammatory cascade, the biologic reduces multiple downstream pathways involved in chronic rhinosinusitis with nasal polyps and other airway diseases. Tezspire is available as a single-use prefilled syringe or auto-injector for self-administration.
Regulatory submissions for Tezspire in chronic rhinosinusitis with nasal polyps are under review in the European Union, China, Japan, and other markets. The European Medicines Agency’s Committee for Medicinal Products for Human Use recently issued a positive opinion for approval. Tezspire is already approved for severe asthma in more than 60 countries, including the US., European Union, and Japan.
Source: AstraZeneca
