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news.Targanta Therapeutics has submitted a new drug application to the FDA for its lead antibiotic candidate, oritavancin, a novel semi-synthetic lipoglycopeptide antibiotic candidate with potent bactericidal activity against a broad spectrum of gram-positive bacteria.
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Oritavancin would be indicated for the treatment of complicated skin and skin structure infections (cSSSI) caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). The oritavancin NDA submission includes data from 19 clinical trials, including two pivotal Phase III clinical trials examining the safety and efficacy of oritavancin in the treatment of cSSSI, both of which met their primary endpoints. Targanta believes oritavancin’s properties may offer distinct advantages in treating patients who have these serious infections.
Mark Leuchtenberger, president and CEO of Targanta, said: “With Phase III trial results showing efficacy in only three to seven days of treatment, we believe oritavancin may become part of a new treatment paradigm for infections caused by MRSA and other gram-positive bacteria, and could confer pharmacoeconomic benefits, if approved.”