Amgen - AstraZeneca's Asthma Candidate Under Priority Review With FDA
- The FDA has accepted for review Amgen Inc's (NASDAQ: AMGN) marketing application seeking approval for tezepelumab to treat asthma.
- Amgen is developing Tezepelumab in collaboration with AstraZeneca plc (NASDAQ: 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.
© 2025 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Posted-In: asthma BriefsBiotech News Health Care Contracts FDA General
