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FDA granted fast track qualification for IL-5 inhibitor Fasenra (benarizumab) for the treatment of eosinophilic gastritis (EG)

 Last Update: 2021-12-03
 Source: Internet
 Author: User

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Eosinophilic gastrointestinal disorder (EGID) is a collective term for a group of diseases, including eosinophilic esophagitis (EoE), eosinophilic gastritis (EG), and Eosinophilic gastroenteritis (eosinophilic gastroenteritis, EGE), eosinophilic enteritis and eosinophilic colitis (eosinophilic colitis, EC)
.

In patients with eosinophilic gastritis and eosinophilic gastroenteritis, excess eosinophils can cause a variety of potentially debilitating gastrointestinal symptoms, including abdominal pain, vomiting, and diarrhea

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Since EG/EGE is relatively rare, there are not many data on its prevalence
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According to previous survey data, the prevalence of EGE in the United States is estimated to be 22/100,000

Recently, AstraZeneca IL-5 inhibitors Fasenra (Tony Canary natalizumab) has received US Food and Drug Administration fast-track designation Bureau, for the treatment of eosinophilic gastritis (EG), with or without Eosinophilic gastroenteritis (EGE)
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The biological therapy has also received orphan drug designation from the FDA for the treatment of EG and EGE

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AZ is launching a phase III clinical trial called HUDSON to evaluate the efficacy and safety of Fasenra in patients with EG and/or EGE
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AZ is launching a phase III clinical trial called HUDSON to evaluate the efficacy and safety of Fasenra in patients with EG and/or EGE

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