AstraZeneca and Amgen Submit BLA to US FDA for Tezepelumab to Treat Severe Asthma

 AstraZeneca and Amgen Submit BLA to US FDA for Tezepelumab to Treat Severe Asthma

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

Click here to­ read full press release/ article | Ref: PRNewswire | Image: Amgen

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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