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news.Targanta Therapeutics has announced that the European Medicines Agency has accepted for review its marketing authorization application for oritavancin, the company's novel semi-synthetic lipoglycopeptide antibiotic candidate with potent bactericidal activity against a broad spectrum of gram-positive bacteria.
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Targanta is seeking approval of intravenous oritavancin in the EU for the treatment of complicated skin and soft tissue infections (cSSTI) caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
The oritavancin marketing authorization application (MAA)includes data from 19 clinical trials, including two pivotal Phase III clinical trials examining the safety and efficacy of intravenous oritavancin in the treatment of cSSTI both of which met their primary endpoints.
Mark Leuchtenberger, president and CEO of Targanta, said: “If regulatory discussions progress as anticipated and approval is received, we expect to launch oritavancin in the US in the first half of 2009. Given the standard regulatory review times in the EU, we hope to receive approval for oritavancin in late 2009.”