The European Medicines Agency (EMA) has accepted The Medicines Company’s (MDCO) investigational intravenous antibiotic, oritavancin, for review of a marketing authorisation application (MAA).
Oritavancin is indicated for the treatment of complicated skin and skin tissue infections (cSSTI) caused by susceptible gram-positive bacteria, including by methicillin-resistant Staphylococcus aureus (MRSA), administered as a single dose.
cSSTI are also known as acute bacterial skin and skin structure infections (ABSSSI).
According to MDCO, acceptance of the MAA marks the beginning of the review process in the European Union (EU) for oritavancin.
The MAA is based on data secured from two Phase III clinical trials, which include SOLO I and SOLO II.
The 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 cSSTI, including infections caused by MRSA.
According to the company, the combined SOLO trials were conducted in 1,959 patients (modified intent-to-treat population, or mITT), with 405 of the patients suffering from a cSSTI with a documented MRSA infection.
Tests showed that the most frequently reported adverse events related with oritavancin were nausea, headache, vomiting and diarrhoea.
The company said that hypersensitivity reactions have been reported with the use of antibacterial agents, including oritavancin.
In February, the US Food and Drug Administration has accepted the filing of MDCO’s new drug application (NDA) for oritavancin with priority review.
The NDA is based on data from the combined SOLO trials which were carried out under a special protocol assessment (SPA) agreement with the FDA.
Image: Scanning electron micrograph of S aureus. Photo: courtesy of Raeky.