Recently, AstraZeneca announced that its IL-5 inhibitor Fasenra (benarizumab) has been approved by the U.S. Food and Drug Administration as a fast-track approval designation for the treatment of with or without eosinophilic gastroenteritis (Eosinophilic Gastroenteritis, EGE) Eosinophilic Gastritis (EG). The biological therapy has also been designated by the FDA as an orphan drug for the treatment of EG and EGE.

Eosinophilic gastroenteritis is a rare digestive system disease characterized by eosinophil infiltration of various segments of the gastrointestinal tract, abnormal gastrointestinal function (from indigestion and obstruction to diarrhea and ascites) and elimination Other diseases are accompanied by increased peripheral eosinophils. Eosinophilic gastritis is a type of eosinophilic gastroenteritis. The stomach and small intestine are usually affected, and patients may have symptoms suggestive of peptic ulcer disease or irritable bowel syndrome.

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

AstraZeneca is initiating a phase III clinical trial called HUDSON to evaluate the efficacy and safety of Fasenra in patients with EG with or without EGE.

Mene Pangalos, Executive Vice President of Research and Development of AstraZeneca’s BioPharmaceuticals, said: “In patients with EGE and EG, excessive eosinophils can cause various debilitating gastrointestinal symptoms, including abdominal pain, Vomiting and diarrhea." "Unfortunately, there is currently no FDA-approved treatment for these diseases. Based on Fasenra's eosinophil depletion mechanism, we hope that it can help address these unmet needs and improve patient treatment outcomes. ."

In the United States, the European Union, Japan and other countries, Fasenra has been approved as an additional maintenance treatment for severe eosinophilic asthma. The therapy is also approved for self-administration in the United States and the European Union, and was previously granted orphan drug designation for the treatment of eosinophilic granuloma with polyangiitis (Eosinophilic Granulomatosis with Polyangiitis, EGPA), eosinophilia (Hypereosinophilic Syndrome, HES) and Eosinophilic Esophagitis (EoE).