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The Medicines Co. announces EMA accepts MAA for oritavancin

The Medicines Company announced that the European Medicines Agency has accepted for review a marketing authorization application for the investigational intravenous antibiotic, oritavancin, for the treatment of complicated skin and skin tissue infections caused by susceptible gram-positive bacteria, including by methicillin-resistant Staphylococcus aureus, administered as a single dose. The oritavancin MAA is based on data from two Phase 3 clinical trials, SOLO I and SOLO II. These Phase 3 trials evaluated the efficacy and safety of a single 1200 mg dose of oritavancin compared to 7 to 10 days of twice-daily vancomycin in adults with cSSTI, including infections caused by MRSA. The combined SOLO studies were conducted in 1,959 patients with 405 of the patients suffering from a cSSTI with a documented MRSA infection. The acceptance of the MAA marks the beginning of the review process in the European Union for oritavancin. Oritavancin is also under review by the US Food and Drug Administration in the U.S.