AstraZeneca: granted orphan drug designation in US
(CercleFinance.com) - AstraZeneca announced on Friday that Tezepelumab, a compound that it is developing with Amgen, has been granted "orphan drug" status by the FDA for the treatment of eosinophilic esophagitis, a rare gastrointestinal disorder.
Eosinophilic esophagitis is a chronic immune-mediated disease of the esophagus that causes predominant inflammation of the esophagus, resulting in symptoms similar to reflux.
Orphan drug designation is granted by the FDA to drugs intended to improve the quality of life of patients with rare diseases, affecting fewer than 200,000 people in the US.
This designation provides a number of benefits, such as seven years of market exclusivity in the US after approval and a waiver of certain registration steps.
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Eosinophilic esophagitis is a chronic immune-mediated disease of the esophagus that causes predominant inflammation of the esophagus, resulting in symptoms similar to reflux.
Orphan drug designation is granted by the FDA to drugs intended to improve the quality of life of patients with rare diseases, affecting fewer than 200,000 people in the US.
This designation provides a number of benefits, such as seven years of market exclusivity in the US after approval and a waiver of certain registration steps.
Copyright (c) 2021 CercleFinance.com. All rights reserved.