Benzinga | Jul 8, 2021 07:01AM EDT

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.