Published on September 11, 2012 at 8:30 AM
Durata Therapeutics (NASDAQ: DRTX) today announced results from its QT
study of the company's lead product candidate, dalbavancin. Dalbavancin
is currently under investigation in two ongoing, global, Phase 3
clinical trials for the treatment of acute bacterial skin and skin
structure infections (ABSSSI). The QT study data, presented at the 52nd
Interscience Conference on Antimicrobial Agents and Chemotherapy
(ICAAC), showed that in this study dalbavancin had no clinically
significant impact on cardiac conduction.
The U.S. Food and Drug Administration (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.
Source: Durata Therapeutics