Amgen - AstraZeneca's Asthma Candidate Under Priority Review With FDA

  • The FDA has accepted for review Amgen Inc's AMGN marketing application seeking approval for tezepelumab to treat asthma. 
  • Amgen is developing Tezepelumab in collaboration with AstraZeneca plc AZN.
  • Under priority review status, the agency's goal date for a decision by the FDA is during Q1 of 2022.
  • Tezepelumab was granted an FDA Breakthrough Therapy Designation for patients with severe asthma without an eosinophilic phenotype in September 2018.
  • Tezepelumab is a human monoclonal antibody that works on the primary source of inflammation: the airway epithelium, which is the first point of contact for viruses, allergens, pollutants, and other environmental insults. 
  • Specifically, tezepelumab targets and blocks thymic stromal lymphopoietin (TSLP), a key epithelial cytokine, and initiates an overreactive immune response to airway inflammation.
  • Price Action: AMGN stock closed at $243.22 on Wednesday, while AZN shares are down 0.9% at $59.21 during the premarket session on the last check Thursday.
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