WelChol colesevelam regulatory update

The European Medicines Agency's CHMP issued a positive opinion to extend the indication of Genzyme's Cholestagel colesevelam to include combination treatment with ezetimibe, with or without a statin, in adults with primary hypercholesterolemia, including patients with familial hypercholesterolemia. The non-absorbed bile acid sequestrant is already approved to treat primary hypercholesterolemia as an add-on to a cholesterol-lowering diet in patients for whom statin therapy is not appropriate or well tolerated, and as an add-on to a statin and a cholesterol-lowering diet. ...