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.
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