AstraZeneca's IL-5 Inhibitor Fasenra Receives FDA Fast Track and Orphan Drug Designations for Eosinophilic Gastritis and Gastroenteritis

Compiled by Fan Dongdong

Recently, AstraZeneca announced that its IL-5 inhibitor Fasenra (benralizumab) has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of eosinophilic gastritis (EG) with or without eosinophilic gastroenteritis (EGE). This biologic therapy also received Orphan Drug designation from the FDA for the treatment of EG and EGE.

Eosinophilic Gastroenteritis: A Rare Digestive System DiseaseEosinophilic gastroenteritis is a rare digestive system disease, characterized by eosinophil infiltration in various segments of the gastrointestinal tract, abnormal gastrointestinal function (ranging from indigestion and obstruction to diarrhea and ascites), and exclusion of other diseases associated with peripheral eosinophilia.

Eosinophilic gastritis is a type of eosinophilic gastroenteritis. The stomach and small intestine are usually involved, and patients may experience symptoms suggestive of peptic ulcer disease or irritable bowel syndrome.

These two indications are both rare, they can coexist or exist independently and are chronic recurrent diseases. The symptoms of this disease are mainly related to eosinophilic tissue inflammation, which may lead to tissue damage or gastrointestinal remodeling.

AstraZeneca is launching a Phase III clinical trial named HUDSON to evaluate the efficacy and safety of Fasenra in patients with EG, with or without EGE.

"In patients with EGE and EG, eosinophil overproduction can lead to various potentially debilitating gastrointestinal symptoms, including abdominal pain, vomiting, and diarrhea," said Mene Pangalos, Executive Vice President of Research and Development at AstraZeneca's BioPharmaceuticals division.

"Unfortunately, there are currently no FDA-approved treatments for these conditions. Based on Fasenra's mechanism of action in depleting eosinophils, we hope it can help address these unmet needs and improve patient outcomes," he added.

In the United States, the European Union, Japan, and other countries, Fasenra has been approved as an add-on maintenance treatment for severe eosinophilic asthma.

The therapy has also been approved for self-administration in the United States and the European Union and was previously granted orphan drug designation for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA), Hypereosinophilic Syndrome (HES), and Eosinophilic Esophagitis (EoE).

Reference Source: AZ announces US fast track designation for IL-5 inhibitor Fasenra