Tezepelumab Regulatory Submission Accepted and Granted FDA Priority Review in the US for the Treatment of Patients with Asthma
These are inflammatory biomarkers used by clinicians to inform treatment options and involve tests analyzing a patients blood (eosinophils/IgE) and exhaled air (FeNO).
- These are inflammatory biomarkers used by clinicians to inform treatment options and involve tests analyzing a patients blood (eosinophils/IgE) and exhaled air (FeNO).
- There were no clinically meaningful differences in safety results between the tezepelumab and placebo groups in the NAVIGATOR trial.
- NAVIGATOR is the first Phase III trial to show benefit in severe asthma irrespective of eosinophils by targeting thymic stromal lymphopoietin (TSLP).
- These results support the US Food and Drug Administration Breakthrough Therapy Designation granted to tezepelumab in September 2018 for patients with severe asthma, without an eosinophilic phenotype.