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LONDON (Alliance News) - AstraZeneca PLC said Monday the US Food & Drug Administration has granted orphan drug designation to Fasenra for the treatment of eosinophilic granulomatosis with polyangiitis, a rare autoimmune disease that can cause damage to multiple organs and tissues.
Eosinophilic granulomatosis with polyangiitis is characterised by inflammation of blood vessels and the presence of elevated levels of eosinophils, a type of white blood cell. The most common symptoms include extreme fatigue, weight loss, muscle and joint pain, rashes, nerve pain, sinus and nasal symptoms, and shortness of breath.
The company said 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 eosinophilic granulomatosis with polyangiitis.
Fasenra 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.
The FDA grants orphan drug designation 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.
Shares in AstraZeneca were trading 0.8% higher at 6,242.00 pence each Monday morning.
