The US Food and Drug Administration has accepted the filing of The Medicines Company’s (MDCO’s) new drug application (NDA) for oritavancin, an investigational intravenous antibiotic, with priority review.
MDCO is seeking approval for Oritavancin 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.
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The NDA is based on data secured from two Phase III clinical trials, SOLO I and SOLO II, which were carried out under a special protocol assessment (SPA) agreement with the FDA.
Phase III trials assessed the efficacy and safety of a single 1,200mg dose of oritavancin compared with seven to ten days of twice-daily vancomycin in adults with ABSSSI, including infections caused by MRSA.
The combined SOLO studies 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.
The FDA designated oritavancin as a qualified infectious disease product (QIDP) in December 2013.
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By GlobalDataThe designation provides oritavancin priority review as well as an additional five years of exclusivity upon approval of the product for the treatment of ABSSSI.
Under priority review, FDA takes action on the application within six months, compared with ten months under standard review.
The FDA assigned a prescription drug user fee act (PDUFA) action date of 6 August 2014.
The Medicines Company vice-president and medical director of infectious disease care Matthew Wikler sai: "We believe that upon approval, oritavancin, administered as a single dose for the treatment of ABSSSI, will offer new options for both physicians and their patients for the treatment of these infections."
Image: Scanning electron micrograph shows a strain of Staphylococcus aureus bacteria. Photo: courtesy of Raeky.
