Benzinga | Dec 20, 2021 05:20AM EST

AstraZeneca - Amgen's Tezspire Biologic Scores FDA Approval For Severe Asthma

The FDA has approved AstraZeneca plc (NASDAQ:AZN) / Amgen Inc's (NASDAQ:AMGN) Tezspire (tezepelumab-ekko) as add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

* Tezspire was approved following a Priority Review by the agency and based on the PATHFINDER clinical trial program results.

* Related content: Benzinga's Full FDA Calendar.

* The application included results from the pivotal NAVIGATOR Phase III trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy.

* Tezspire is a first-in-class biologic for severe asthma that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin, an epithelial cytokine.

* In clinical studies, the most common adverse reactions in patients who received Tezspire were pharyngitis, arthralgia, and back pain.

* Tezspire is under regulatory review in the EU, Japan, and several other countries.

* Price Action: AZN shares closed at $56.02, AMGN stock closed at $222.50 on Friday.