General Information

Kimyrsa (oritavancin) is a single-dose, long-acting lipoglycopeptide antibiotic with rapid bactericidal activity.

Kimyrsa is specifically indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (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), and Enterococcus faecalis (vancomycin-susceptible isolates only).

Kimyrsa is formulated to provide oritavancin with a shorter infusion time and lower infusion volume compared to another oritavancin product, Orbactiv.

Kimyrsa is supplied as a solution for intravenous infusion. The recommended dosage of Kimyrsa is 1,200 mg administered as a single dose by intravenous infusion over 1 hour.

Mechanism of Action

Kimyrsa (oritavancin) is a single-dose, long-acting lipoglycopeptide antibiotic with rapid bactericidal activity. Oritavancin has three mechanisms of action: (i) inhibition of the transglycosylation (polymerization) step of cell wall biosynthesis by binding to the stem peptide of peptidoglycan precursors; (ii) inhibition of the transpeptidation (crosslinking) step of cell wall biosynthesis by binding to the peptide bridging segments of the cell wall; and (iii) disruption of bacterial membrane integrity, leading to depolarization, permeabilization, and cell death. These multiple mechanisms contribute to the concentration-dependent bactericidal activity of oritavancin.

Clinical Trial Results

The FDA approval of Kimyrsa was based on the randomized, double-blind, multicenter SOLO studies that evaluated a single 1,200 mg IV dose of oritavancin against twice-daily vancomycin for the treatment of ABSSSI in 1,987 adult patients and assessed a large subset of documented MRSA infection (405 patients). These trials demonstrated that 1,200 mg one-dose IV oritavancin infusion was as effective as 7-to-10 days of twice-daily vancomycin (1 g or 15 mg/kg) for the primary and secondary endpoints. Kimyrsa was also evaluated in an open-label, multi-center, pharmacokinetics study, which compared Kimyrsa administered over 1 hour (N=50) to Orbactiv administered over 3 hours (N=52) for the treatment of adult patients with ABSSSI.