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AstraZeneca: FDA Grants Orphan Drug Designation To Tezepelumab For Eosinophilic Esophagitis

British drug major AstraZeneca Plc. (AZN,AZN.L) announced Friday that the U.S. Food and Drug Administration or FDA has granted Orphan Drug Designation to Tezepelumab for the treatment of eosinophilic esophagitis or EoE.

Tezepelumab is being developed by AstraZeneca in collaboration with Amgen. It is under Priority Review for patients with asthma in the US.

The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.

EoE is a rare, chronic, inflammatory disease which involves a range of inflammatory cells that contribute to debilitating symptoms for patients, including severe pain and difficulty swallowing food. There are currently no approved treatments for eosinophilic esophagitis in the US.

The companies expect a decision on tezepelumab's Priority Review in patients with asthma in the US in the first quarter of 2022. Tezepelumab is also under regulatory review for asthma in the EU and Japan.

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