FDA Panel Backs Sanofi (France) (SAN.PA) and Isis Pharmaceuticals, Inc. (ISIS) Drug for Rare Genetic Disorder
10/19/2012 6:56:47 AM
A U.S. Food and Drug Administration panel of outside experts recommended the Sanofi SA and Isis Pharmaceutical Inc drug, Kynamro, for treatment of a rare genetic disorder that causes unusually high cholesterol and life-threatening cardiovascular disease. In a 9-6 vote on Thursday, the FDA advisory committee concluded that company-provided research showed the 200 milligram injection to be safe and effective enough for the one in 1 million Americans who have homozygous familial hypercholesterolemia, or HoFH, and are already on a cholesterol treatment regimen that includes lipid-lowering medication. The panel's recommendation, reached despite misgivings about side-effects, including liver problems and a potentially higher risk for cancer, will now be considered by FDA regulators as they decide by the end of January whether to grant final approval for the drug known generically as mipomersen sodium. The shares of Isis, which developed the drug in cooperation with Sanofi, were halted on Thursday because of the FDA meeting. They closed at $9.62 on Wednesday. Sanofi's shares closed up 1.3 percent at 69.65 euros in Europe before the panel reached its decision.