Tezspire™ (tezepelumab-ekko) is now available for the add-on maintenance treatment of patients 12 years of age and older with severe asthma.
Tezspire is a human monoclonal antibody that works by blocking thymic stromal lymphopoietin, an epithelial cytokine involved in the initiation and persistence of airway inflammation. It is the first treatment for severe asthma that is not limited to a specific phenotype or biomarker.
The approval was based on data from the phase 3 NAVIGATOR (ClinicalTrials.gov Identifier: NCT03347279) and phase 2 PATHWAY (ClinicalTrials.gov Identifier: NCT02054130) trials, which included a total of 1609 patients 12 years of age and older with severe asthma who had a history of 2 or more asthma exacerbations requiring oral or injectable corticosteroid treatment or resulting in hospitalization in the past 12 months.
Findings from both trials showed that treatment with Tezspire significantly reduced the annualized rate of asthma exacerbations compared with placebo. Moreover, Tezspire was associated with a lower rate of asthma exacerbations requiring an emergency room visit or hospitalization.
The most common adverse reactions reported with Tezspire were pharyngitis, arthralgia, and back pain. Hypersensitivity reactions can occur within hours or days following administration.
Tezspire is supplied as a single-dose vial or prefilled syringe containing 210mg/1.91mL of tezepelumab-ekko. Treatment is administered subcutaneously by a health care provider once every 4 weeks.
Provider and patient product resources and support are available through the Tezspire Together Program.
- Tezspire™ (tezepelumab-ekko) now available in the united states for the treatment of severe asthma. News release. Amgen. Accessed January 13, 2022. https://www.prnewswire.com/news-releases/tezspire-tezepelumab-ekko-now-available-in-the-united-states-for-the-treatment-of-severe-asthma-301460118.html.
- Tezspire. Package insert. Amgen; 2021. Accessed December 20, 2021. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761224s000lbl.pdf.