EU approves use of Orbactiv (oritavancin) for ABSSSI- The Medicines Co.

The European Commission has granted marketing authorization for Orbactiv (oritavancin), from The Medicines Co, for acute bacterial skin and skin structure infections, including those caused by Methicillin-resistant Staphylococcus aureus or MRSA and others. A new drug application for Orbactiv was approved by the FDA in August 2014 after designation as a Qualified Infectious Disease Product.

In addition to the necessary bacterial killing qualities needed for these serious infections, Orbactiv is given as a single dose which brings potential economic savings when compared to multiple days of intravenous infusions with the older product, vancomycin. Researchers believe that long-acting antibiotics, such as Orbactiv, with its single, once-only dosing regimen for ABSSSI, have the potential to be transformative in the treatment of patients with skin infections where MRSA is suspected, by simplifying the management of these infections.

The Marketing Authorization Application submission for Orbactiv to the EMA was based on the results of the SOLO I and SOLO II clinical trials which were randomized, double-blind, multi-center trials that evaluated a single 1200 mg IV dose of Orbactiv for the treatment of ABSSSI in 1,987 patients, and assessed a large subset of patients with documented MRSA infection (405 patients). These trials demonstrated non-inferiority for the primary and secondary endpoints evaluating 1200 mg once-only Orbactiv IV dose, versus 7-to-10 days of twice-daily vancomycin (1 g or 15 mg/kg). Orbactiv approval in the US in August 2014 was also based on the results of the SOLO I and SOLO II clinical trials.