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FDA Grants Priority Review to Intravenous Antibiotic Oritavancin
Approval decision expected in August 2014 (February 19)
The FDA has accepted the filing of a new drug application (NDA) for oritavancin, an investigational intravenous antibiotic, with priority review.
The drug’s developer (The Medicines Company) is seeking approval of oritavancin for the treatment of acute bacterial skin and skin-structure infections (ABSSSIs) caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), administered as a single dose.
The FDA action date (PDUFA date) for oritavancin is August 6, 2014.
The NDA submission for oritavancin was based on data from two phase III clinical trials (SOLO I and SOLO II), which evaluated the efficacy and safety of a single 1,200-mg dose of oritavancin compared with 7 to 10 days of twice-daily vancomycin in adults with ABSSSIs, including infections caused by MRSA. The combined SOLO studies were conducted in 1,959 patients. A total of 405 patients had an ABSSSI with a documented MRSA infection.
In clinical trials, the most frequently reported adverse events associated with oritavancin were nausea, headache, vomiting, and diarrhea. Hypersensitivity reactions have been reported with the use of antibacterial agents, including oritavancin.
Source: The Medicines Company; February 19, 2014.