US FDA grants orphan status for AstraZeneca's Fasenra

(Sharecast News) - AstraZeneca on Monday said its Fasenra treatment for the autoimmune disease eosinophilic granulomatosis with polyangiitis (EGPA) had been granted Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA).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.EGPA is a potentially fatal rare autoimmune disease that can cause damage to multiple organs and tissues, including lungs, skin, heart, gastrointestinal tract and nerves.The most common symptoms include extreme fatigue, weight loss, muscle and joint pain, rashes, nerve pain, sinus and nasal symptoms, and shortness of breath.Without treatment, the disease may be fatal.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."There are few effective medicines for EGPA. Patients are often treated with chronic high-dose oral corticosteroids (OCS) and can experience recurrent relapses when attempting to taper off OCS," Astra said.