FDA OKs Isis Orphan Drug Amid Shareholder's Safety Suit

Law360, New York (January 30, 2013, 7:47 PM EST) -- The Food and Drug Administration announced Tuesday that it approved Kynamro as an orphan drug treatment for a rare type of high cholesterol, a drug whose safety concerns prompted a shareholder suit last month against Isis Pharmaceuticals Inc.

Along with Genzyme, a unit of Sanofi, Isis developed Kynamro, a mipomersen sodium injection, to treat an inherited cholesterol disorder called homozygous familial hypercholesterolemia. The FDA said in its announcement that the drug, used in addition to lipid-lowering medications and diet, will help reduce so-called bad cholesterol in...
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