Benzinga | Nov 8, 2021 05:01AM EST

AstraZeneca Says Fasenra Granted Orphan Drug and Fast Track Designations by the FDA For Eosinophilic Gastritis And Eosinophilic Gastroenteritis

Fasenra (benralizumab) has been granted Orphan Drug Designations (ODDs) for the treatment of eosinophilic gastritis (EG) and eosinophilic gastroenteritis (EGE) as well as a Fast Track Designation (FTD) for the treatment of EG with or without EGE in the US by the Food and Drug Administration (FDA).

EG and EGE are rare, chronic relapsing conditions that may co-exist or be independent.1-3 These diseases have symptoms that are primarily related to eosinophilic tissue inflammation, which can cause tissue injury and remodelling of the gastrointestinal tract.1-5

The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.6 FTD status is granted for medicines in the US 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.7

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: "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 diarrhoea. 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 characterised 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.8,9

A Phase III clinical trial (HUDSON) is initiating to evaluate the efficacy and safety of Fasenra in patients with EG and/or EGE.10

Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries11 and is approved for self-administration in the US12 and EU.13 The FDA granted ODD for Fasenra for eosinophilic granulomatosis with polyangiitis (EGPA) (November 2018),14 hypereosinophilic syndrome (HES) (February 2019)15 and eosinophilic esophagitis (EoE) (August 2019).16