Shots:

• The BLA is based on PATHFINDER clinical program- including P-III NAVIGATOR study evaluating Tezepelumab + SOC vs PBO + SOC in 1-061 adults (18–80yrs.) & adolescents (12–17yrs.) with severe & uncontrolled asthma who receive treatment with medium/high dose ICS + at least 1 additional controller medication with/out OCS
• The results demonstrated superiority in 1EP & 2EP in broad population- 56% reduction in AAER @52wks in an overall population. In prespecified analyses- AAER @52wks. was also evaluated in patients with baseline blood eosinophil count- FeNO level- IgE status
• Additionally- no clinical differences were observed in the safety results. The anticipated PDUFA date is in Q1’22

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