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news.The Medicines Company (MDCO) has announced that the US Food and Drug Administration (FDA) has accepted the filing of a new drug application (NDA) for its investigational intravenous antibiotic 'oritavancin', with priority review.
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The company is seeking approval of oritavancin is for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), administered as a single dose.
In December 2013, the FDA had designated oritavancin as a Qualified Infectious Disease Product (QIDP).
The designation provides oritavancin priority review as well as additional five years of exclusivity upon approval of the product for the treatment of ABSSSI.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of 06 August 2014.
The NDA is based on data from two Phase III clinical trials, SOLO I and SOLO II, which were conducted under a Special Protocol Assessment (SPA) agreement with the FDA.
The Phase III trials evaluated the efficacy and safety of a single 1200mg dose of oritavancin compared to 7 to 10 days of twice-daily vancomycin in adults with ABSSSI, including infections caused by MRSA.
The combined SOLO trials were carried out in about 1,959 patients (modified intent-to -treat population, or mITT), with 405 of the patients suffering from an ABSSSI with a documented MRSA infection.