The Medicines Company announced that the FDA has approved Orbactiv (oritavancin), the first and only single dose antibiotic administered intravenously for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible designated Gram-positive bacteria.
The approval is based on the results of the SOLO I and SOLO II clinical trials of randomized, double-blind multicenter studies on the efficacy of a single 1200mg IV dose of Orbactiv in 1,987 patients, 405 of whom had documented Methicillin-resistant Staphylococcus aureus (MRSA) infection. Orbactiv demonstrated non-inferiority to 7–10 days of twice-daily vancomycin (1g or 15mg/kg) in primary and secondary endpoints.
Orbactiv is a lipoglycopeptide with bactericidal activity against Gram-positive bacteria. It is indicated for the treatment of ABSSSI caused by susceptible isolates of the following Gram-positive microorganisms:
- Staphylococcus aureus (including methicillin-susceptible and methicillin–resistant isolates)
- Streptococcus pyogenes
- Streptococcus agalactiae
- Streptococcus dysgalactiae
- Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus)
- Enterococcus faecalis (vancomycin-susceptible isolates only)
Orbactiv will be available as 400mg of lyophilized powder in a single-use vial for reconstitution. It is expected to launch in the second half of 2014.
For more information visit TheMedicinesCompany.