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US FDA grants Fasenra ODD for EGPA
US FDA grants Fasenra ODD for EGPA.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 4078I AstraZeneca PLC 26 November 2018 \n\n26 November 2018 07:00 GMT\nUS FDA grants Fasenra Orphan Drug Designation\nfor Eosinophilic Granulomatosis with Polyangiitis\n \nAstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for Fasenra (benralizumab) for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA).\n \nEGPA is a rare autoimmune disease that can cause damage to multiple organs and tissues.1 The FDA grants ODD status to medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.\n \nSean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: \"EGPA is a rare, but debilitating inflammatory disease and patients with the disease typically have very high levels of eosinophils. Our clinical trials for Fasenra in severe, eosinophilic asthma show it depletes eosinophils and we are exploring the potential of this medicine to address unmet medical needs in other eosinophil-driven diseases.\"\n \nEGPA is characterised by inflammation of blood vessels and the presence of elevated levels of eosinophils, a type of white blood cell.1 Fasenra induces rapid and near-complete depletion of eosinophils in the blood and has proven efficacy in severe, eosinophilic asthma, which suggests it may benefit patients with EGPA.2,3\n \nFasenra is AstraZeneca's first respiratory biologic and is currently approved as an add-on maintenance treatment for severe, eosinophilic asthma in the US, EU, Japan and several other jurisdictions.\n \nAbout EGPA\nEGPA, formerly known as Churg-Strauss Syndrome, is a rare, chronic autoimmune disease that is caused by inflammation of small to medium-sized blood vessels.4 EGPA can result in damage to multiple organs, including lungs, skin, heart, gastrointestinal tract and nerves.1 The most common symptoms include extreme fatigue, weight loss, muscle and joint pain, rashes, nerve pain, sinus and nasal symptoms, and shortness of breath.1,4,5 Without treatment, the disease may be fatal.1\n \nElevated levels of eosinophils play a central role in EGPA disease pathophysiology. All patients with EGPA have very high levels of eosinophils at some point in their disea...