General Information

Tezspire (tezepelumab-ekko) is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ).

Tezspire is specifically indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

Tezspire is supplied as an injection for subcutaneous administration. The recommended dosage is 210 mg administered subcutaneously once every 4 weeks. If a dose is missed, administer the dose as soon as possible. Thereafter, the patient can continue (resume) dosing on the usual day of administration. If the next dose is already due, then administer as planned.

Mechanism of Action

Tezspire (tezepelumab-ekko) is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ) that binds to human TSLP and blocks its interaction with the TSLP receptor. TSLP is a cytokine mainly derived from epithelial cells and occupies an upstream position in the asthma inflammatory cascade. Airway inflammation is an important component in the pathogenesis of asthma. Multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes, ILC2 cells) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) are involved in airway inflammation. Blocking TSLP with tezepelumab-ekko reduces biomarkers and cytokines associated with inflammation including blood eosinophils, airway submucosal eosinophils, IgE, FeNO, IL-5, and IL-13; however, the mechanism of tezepelumab-ekko action in asthma has not been definitively established.

Side Effects

Adverse effects associated with the use of Tezspire may include, but are not limited to, the following:

• pharyngitis
• arthralgia
• back pain

Clinical Trial Results

FDA approval was based on results from the PATHFINDER clinical trial program. The application included results from the pivotal NAVIGATOR Phase 3 trial. The multicenter, randomized, double-blind, placebo-controlled trial enrolled 1,061 patients (12 to 80 years of age) with severe, uncontrolled asthma. Patients were randomly assigned to receive tezepelumab (210 mg) or placebo subcutaneously every 4 weeks for 52 weeks. The primary end point was the annualized rate of asthma exacerbations over a period of 52 weeks. This end point was also assessed in patients with baseline blood eosinophil counts of less than 300 cells per microliter. The annualized rate of asthma exacerbations was 0.93 with tezepelumab and 2.10 with placebo. In patients with a blood eosinophil count of less than 300 cells per microliter, the annualized rate was 1.02 with tezepelumab and 1.73 with placebo.