AstraZeneca's Tezepelumab Gets Orphan Drug Designation in the US
October 08 2021 - 7:53AM
Dow Jones News
By Joe Hoppe
AstraZeneca PLC said Friday that its Tezepelumab drug for
treating eosinophilic esophagitis--a rare, chronic, inflammatory
disease--has been granted orphan drug designation in the U.S.
The London-listed biopharmaceutical company said Tezepelumab is
designed to treat eosinophilic esophagitis--a disease that occurs
when eosinophils, a type of white blood cell builds up in the
esophagus. Along with eosinophils, other cells including mast
cells, T-cells and firbroblasts cause further injury, inflammation
and detrimental tissue remodeling.
If untreated, the disease can cause difficulty and discomfort in
eating, leading to chronic pain, difficulty in swallowing, poor
growth, malnutrition and weight loss.
The orphan drug designation qualifies Tezepelumab for government
assistance and incentives to continue developing the product
despite the extremely rare nature of the disease and consequent
lack of profitability.
A decision on Tezepelumab's priority review in patients with
asthma in the U.S. is expected in the first quarter of 2022, and
the drug is also under regulatory review for asthma in the European
Union and Japan.
Write to Joe Hoppe at joseph.hoppe@wsj.com
(END) Dow Jones Newswires
October 08, 2021 07:38 ET (11:38 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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