FDA Grants Fast Track Designation to AstraZeneca’s Fasenra for Eosinophilic Gastritis
November 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. These diseases have symptoms that are primarily related to eosinophilic tissue inflammation, which can cause tissue injury and remodeling of the gastrointestinal tract. These diseases can result in a variety of debilitating gastrointestinal symptoms such as abdominal pain, nausea, vomiting, satiety (feeling overfull), loss of appetite, and diarrhea. There are no approved treatments. Disease management includes strict dietary changes with more severe patients receiving locally acting or oral corticosteroids. Patients’ vigilant monitoring of a likely restricted diet, with potential to affect adequate and balanced nutrition, has a severe impact on their daily lives.
Fast Track status is granted to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need so that important new drugs get to the patient earlier.
“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.”
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.
A phase 3 clinical trial (HUDSON) is initiating to evaluate the efficacy and safety of Fasenra in patients with EG and/or EGE.
Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the U.S., EU, Japan and other countries. The FDA previously granted Orphan Drug designation for Fasenra for eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), and eosinophilic esophagitis (EoE).
Fasenra is in development for other eosinophilic diseases including atopic dermatitis, bullous pemphigoid, chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, eosinophilic esophagitis, eosinophilic gastritis/eosinophilic gastroenteritis, eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome and non-cystic fibrosis bronchiectasis.
Author: Rare Daily Staff
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