The Food and Drug Administration (FDA) has approved Tezspire™ (tezepelumab-ekko) for the add-on maintenance treatment of patients 12 years of age and older with severe asthma.

Tezspire is a first-in-class human monoclonal antibody that works by blocking thymic stromal lymphopoietin, an epithelial cytokine involved in the initiation and persistence of airway inflammation. The approval was based on data from the phase 3 NAVIGATOR ( Identifier: NCT03347279) and phase 2 PATHWAY ( Identifier: NCT02054130) trials. 

In the NAVIGATOR trial, 1061 patients 12 years of age and older were randomly assigned 1:1 to receive tezepelumab 210mg subcutaneously every 4 weeks or placebo, in addition to standard of care. The primary endpoint was the annualized asthma exacerbation rate during the 52-week treatment period.

Results from NAVIGATOR showed that treatment with tezepelumab was associated with a statistically significant and clinically meaningful 56% reduction in annualized asthma exacerbation rate in the overall patient population compared with placebo (0.93 vs 2.10; rate ratio, 0.44 [95% CI, 0.37-0.53]; P <.001). Moreover, tezepelumab was associated with a significantly lower rate of annualized asthma exacerbations requiring an emergency room visit or hospitalization (0.06 vs 0.28 for placebo; rate ratio, 0.21 [95% CI, 0.12-0.37]).

Compared with placebo, tezepelumab provided clinically meaningful improvements in the mean change from baseline in FEV1 (LS mean change vs placebo 0.13 L; 95% CI, 0.08-0.18), as well as in patient reported outcomes, as measured by the Asthma Control Questionnaire 6 and Standardized Asthma Quality of Life Questionnaire for ages 12 and older.

Similar findings were observed in the 52-week PATHWAY trial, which enrolled 550 adult patients with severe asthma. Tezepelumab significantly reduced the annualized rate of asthma exacerbations compared with placebo (0.20 vs 0.72; rate ratio, 0.29 [95% CI, 0.16-0.51]).

A total of 82 pediatric patients aged 12 to 17 years were enrolled in the NAVIGATOR trial. Compared with placebo, improvements in annualized asthma exacerbation (rate ratio 0.70; 95% CI, 0.34-1.46) and FEV1 (LS mean change vs placebo 0.17 L; 95% CI, -0.01, 0.35) were observed in patients treated with tezepelumab.

The most common adverse reactions reported with tezepelumab included pharyngitis, arthralgia, and back pain.

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.

“Today’s approval by the FDA marks the first time patients and their physicians will have a biologic option for severe asthma without phenotypic limitations and irrespective of biomarker levels,” said David M. Reese, MD, executive vice president of Research and Development at Amgen. “By working at the top of the inflammation cascade, Tezspire helps stop the inflammation that causes asthma attacks at the source and has the potential to treat a broad population of people with severe asthma, including those who have historically lacked effective treatment options.”


  1. FDA approves Tezspire™ (tezepelumab-ekko) in the US for severe asthma. News release. Amgen. December 17, 2021. Accessed December 20, 2021.
  2. Tezspire. Package insert. Amgen; 2021. Accessed December 20, 2021.