FDA Grants Fast Track Designation to AstraZeneca’s Fasenra for Eosinophilic Gastritis

发布时间： 2021-11-10 阅读：513次

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Nov. 8, 2021 -- The U.S. Food and Drug Administration granted Fast Track designation to AstraZeneca’s Fasenra for the treatment of eosinophilic gastritis with or without eosinophilic gastroenteritis. Fasenra was also granted Orphan Drug designations for the treatment of eosinophilic gastritis (EG) and eosinophilic gastroenteritis (EGE), rare, chronic relapsing conditions that may co-exist or be independent. 

EG and EGE may be driven by eosinophilic immune dysfunction (EID), a process characterized by the dysregulation of biological mechanisms involved with eosinophil recruitment and activation that enable eosinophils to infiltrate patients’ tissue to cause and worsen disease in a range of tissues and organ systems throughout the body.

Fasenra (benralizumab) is a monoclonal antibody that binds directly to IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of blood and tissue eosinophils in most patients via apoptosis (programmed cell death). It was developed by AstraZeneca and is in-licensed from BioWa, a wholly owned subsidiary of Kyowa Kirin.

“In patients with eosinophilic gastritis and eosinophilic gastroenteritis, an excess of eosinophils contributes to a variety of potentially debilitating gastrointestinal symptoms, including abdominal pain, vomiting, and diarrhea.” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca. “Unfortunately, there are currently no FDA-approved treatments for these diseases. Based on Fasenra’s eosinophil-depleting mechanism of action, we’re hopeful it can help address these unmet needs and improve patient outcomes.”