FDA approves Orbactiv for ABSSSI - Medicines Co

The FDA has approved Orbactiv (oritavancin), from The Medicines Company, for injection for the treatment of adults with Acute Bacterial Skin and Skin Structure Infections (ABSSSIs) caused by susceptible designated Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA). Orbactiv is the first and only antibiotic approved by FDA to treat ABSSSIs with a single, once-only administration. Once fully infused over three hours, the Orbactiv treatment regimen is complete for patients with skin infections caused by susceptible Gram-positive pathogens.

Orbactiv approval is based on the results of the SOLO I and SOLO II clinical studies which were randomized, double-blind, multicenter 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 IV Orbactiv dose infusion, versus 7-to-10 days of twice-daily vancomycin (1 g or 15 mg/kg).