The Food and Drug Administration (FDA) has granted Orphan Drug designations to benralizumab for the treatment of eosinophilic gastritis and eosinophilic gastroenteritis, as well as Fast Track designation for the treatment of eosinophilic gastritis with or without eosinophilic gastroenteritis.

These rare, chronic relapsing conditions are primarily associated with eosinophilic tissue inflammation that leads to tissue injury and remodeling of the gastrointestinal tract. Patients may present with symptoms such as abdominal pain, nausea, vomiting, satiety, loss of appetite, and diarrhea.

Benralizumab is a monoclonal antibody (IgG1, kappa) that binds to interleukin-5 receptor alpha on eosinophils causing apoptosis. Currently, there are no FDA-approved treatments for eosinophilic gastritis and eosinophilic gastroenteritis. The Company is initiating the phase 3 HUDSON trial to evaluate the efficacy and safety of benralizumab in patients with these inflammatory diseases.

“Based on [benralizumab’s] eosinophil-depleting mechanism of action, we’re hopeful it can help address these unmet needs and improve patient outcomes,” said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca.


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Benralizumab is currently marketed under the brand name Fasenra and is indicated as an add-on maintenance treatment for patients 12 years of age and older with severe asthma and with an eosinophilic phenotype.

Reference

Fasenra granted Orphan Drug and Fast Track designations in the US for eosinophilic gastritis and eosinophilic gastroenteritis. News release. AstraZeneca. November 8, 2021. Accessed November 9, 2021. https://www.astrazeneca.com/content/astraz/media-centre/medical-releases/fasenra-granted-orphan-drug-and-fast-track-designations-in-the-us-for-eosinophilic-gastritis-and-eosinophilic-gastroenteritis.html