Policy & Regulation
AstraZeneca wins FDA's ODD for Tezepelumab
11 October 2021 -

Biopharmaceutical company AstraZeneca reported on Friday the receipt of the US Food and Drug Administration's (FDA) Orphan Drug Designation (ODD) for Tezepelumab for the treatment of eosinophilic esophagitis (EoE), a rare, chronic, inflammatory disease that occurs when eosinophils, a type of white blood cell, accumulate in the esophagus.

In collaboration with Amgen, Tezepelumab is being developed under Priority Review for patients with asthma in the US. A decision on tezepelumab's Priority Review in patients with asthma in the US is expected in the Q1 2022, said the company.

According to the company, Tezepelumab is under regulatory review for asthma in the EU and Japan. In EoE, a Phase III trial is planned.

The partnership is developing Tezepelumab as the potential first-in-class human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades. Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, which are implicated in the epithelial disease pathophysiology of diseases.