AstraZeneca and Amgen Report the US FDA’s Acceptance of BLA and Priority Review of Tezepelumab for the Treatment of Asthma

July 8, 2021 Auto Bot Amgen, Asthma, AstraZeneca, BLA, FDA, Priority Review, regulatory, Tezepelumab 0

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

Click here to read full press release/ article | Ref: AstraZeneca | Image: Business Standard

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