The Food and Drug Administration on Friday granted expanded approval for Alexion Pharmaceuticals' best-selling ultra-rare disease drug Soliris.
The agency first approved Soliris in 2007 to treat paroxysmal nocturnal hemoglobinuria, a rare, life-threatening blood disease. The drug may now also be used to treat adults with generalized myasthenia gravis — an autoimmune disorder that affects the body's intramuscular system.
Soliris is the first treatment approved to treat generalized myasthenia gravis in more than 60 years.
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