Dalbavancin (Durata Therapeutics) QT study results

Results from a QT study of dalbavancin from Durata Therapeutics were presented at the 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and showed that in this study dalbavancin had no clinically significant impact on cardiac conduction. The drug is currently under investigation in two ongoing, global, Phase III clinical trials for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The FDA generally requires thorough QT studies for new chemical entities due to the risk of heart arrhythmias associated with some pharmaceutical products. The results observed in Durata's definitive study are intended to satisfy the FDA's requirements in this area. These data will be included in the company's New Drug Application (NDA) for dalbavancin, which Durata anticipates submitting with the FDA in the first half of 2013