Invirase saquinavir regulatory update

FDA approved an updated label for Invirase saquinavir from Roche to warn of the risk of abnormal heart rhythms when the HIV drug is boosted with Norvir ritonavir from Abbott Laboratories (NYSE:ABT, Abbott Park, Ill.). In February, FDA said it was reviewing the safety of Invirase after data from a QT study of the combination in healthy volunteers showed a dose-dependent prolongation of the QT and PR intervals, which could lead to torsades de pointe - a frequently fatal arrhythmia - and heart block, respectively (see BioCentury, March 1). ...