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

AstraZeneca’s IL-5 inhibitor Fasenra (benralizumab) has received a fast-track designation from the US Food and Drug Administration for the treatment of eosinophilic gastritis (EG), with or without eosinophilic gastroenteritis (EGE).

The biologic treatment has also been granted orphan drug designations from the FDA for the treatment of EG and EGE.

Both conditions are rare but chronic relapsing conditions that can co-exist or be independent – symptoms of the disease are primarily related to eosinophilic tissue inflammation, which can lead to tissue injury or remodelling of the gastrointestinal tract.

AZ is initiating a Phase III clinical trial – dubbed HUDSON – which will aim to evaluate the efficacy and safety of Fasenra in patients with EG and/or EGE.

“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,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AZ.

“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,” he added.

In the US, EU, Japan and other countries, Fasenra is already approved as an add-on maintenance treatment for severe eosinophilic asthma.

The treatment is also approved for self-administration in both the US and EU and also has previously been granted orphan drug designation for eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES) and eosinophilic esophagitis (EoE).