Alexion Pharmaceuticals announced that the FDA has granted Orphan Drug designation to Soliris (eculizumab) for the treatment of patients with myasthenia gravis, a rare debilitating neurologic disorder caused by uncontrolled complement activation.

Alexion is currently enrolling patients in a multinational, placebo-controlled registration trial of eculizumab in patients with refractory generalized myasthenia gravis.

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Soliris is a first-in-class terminal complement inhibitor, already approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).

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