Shots:

• The submission is based on PATHFINDER clinical program including P-III NAVIGATOR that involves assessing Tezepelumab + SOC vs PBO + SOC in 1061 adults (18–80yrs.) & adolescents (12–17yrs.) with severe and uncontrolled asthma
• The study demonstrated 56% reduction in AAER @52wks. in the overall population. The study also met 1EPs in the subgroup of patients i.e. 41% reduction in low levels of eosinophils <300 cells/microliter- improvements in lung function measurements- asthma control & health related QoL
• Tezepelumab is the only biologic to reduce AAER consistently in a broad population of severe asthma patients irrespective of the baseline eosinophil counts across P-II & P-III studies

  Ref: PRNewswire | Image: Amgen