FDA grants Orphan Drug Designation to Alexion Pharmaceuticals Inc 's Soliris (eculizumab)

Tuesday, 17 Jun 2014 06:39am EDT 

Alexion Pharmaceuticals Inc:Says U.S. FDA has granted orphan drug designation (ODD) to Soliris.Soliris (eculizumab) used for treatment of patients with Myasthenia Gravis (MG), a rare, debilitating neurologic disorder caused by uncontrolled complement activation.In patients with MG, uncontrolled complement activation due to antibodies directed at neuromuscular junction can ultimately lead to profound and debilitating weakness of various muscle groups throughout body.Oliris is first-in-class terminal complement inhibitor and is currently approved for treatment of patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. 

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