Targanta Therapeutics Corporation announced that oritavancin, the Company’s investigational antibiotic therapy for the treatment of complicated skin and skin structure infections (cSSSI) caused by gram-positive pathogens, including methicillin resistant Staphylococcus aureus (MRSA), received a mixed review from the United States Food and Drug Administration’s (FDA) Anti-Infective Drugs Advisory Committee.
During today's meeting, the Advisory Committee voted 11-6 (with one abstaining) that clinical study ARRI independently provides evidence of the effectiveness of oritavancin for cSSSI. The Advisory Committee voted 8 to 10 (against) that clinical study ARRD independently provides evidence of the effectiveness of oritavancin for cSSSI. Finally, the Advisory Committee voted by a narrow margin of 8-10 (against) that the data presented demonstrate the safety and effectiveness of oritavancin for the treatment of cSSSI.
Mark Leuchtenberger, President and CEO of Targanta, commented, "We obviously are disappointed with the recommendation of the Advisory Committee, but we firmly believe that oritavancin’s safety profile to-date and its unique pharmacokinetic profile confirm its potential to change treatment paradigms in cSSSI and other serious bacterial infections. We will continue our discussions with the FDA as it completes its review of oritavancin.”
While the Advisory Committee's recommendation is not binding, the Advisory Committee’s guidance will be considered by the FDA in its review of the New Drug Application (NDA) that Targanta submitted for oritavancin in February 2008. The target PDUFA date for oritavancin is December 8, 2008.