FDA Panel Backs Sanofi SA, Isis Pharmaceutical Inc Drug For Rare Disorder-Reuters

Reuters reported that a U.S. Food and Drug Administration panel of outside experts recommended Sanofi SA's and Isis Pharmaceutical Inc's drug, Kynamro, for treatment of a rare genetic disorder that causes unusually high cholesterol and life-threatening cardiovascular disease. n a 9-6 vote on Thursday, the FDA advisory committee concluded that company-provided research showed the drug 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.