Oritavancin (KIMYRSA™) in acute bacterial skin and skin structure infections: a profile of its use in the USA

Abstract

Oritavancin, a long-acting lipoglycopeptide, is the first single-dose intravenous (IV) antibacterial therapy approved in the USA for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSIs) caused or suspected to be caused by susceptible isolates of designated gram-positive microorganisms. With its well-established antibacterial activity, efficacy and safety profiles, a new IV formulation of oritavancin (KIMYRSA™) has been developed to offer a more convenient treatment option for patients with ABSSSIs. Relative to the originally approved IV formulation of oritavancin (ORBACTIV ® ), the new IV formulation has better diluent compatibility, simpler preparation steps, a shorter infusion time of 1 h in a lower infusion volume of 250 mL. Approval was based on results of a phase 1 study in which pharmacokinetic similarity between the two IV formulations of oritavancin was demonstrated in patients with ABSSSIs. The tolerability profile of the new IV formulation of oritavancin revealed no new safety signals. Plain Language SummaryAcute bacterial skin and skin structure infections (ABSSSIs) are heterogeneous bacterial infections that can pose a significant burden on healthcare systems. In an attempt to optimize patient outcomes and healthcare utilizations, single-dose regimens have been developed as an alternative to multi-dose and multi-day regimens for ABSSSIs. Oritavancin is the first singledose intravenous (IV) antibacterial therapy approved in the USA for the treatment of adult patients with ABSSSIs. With its well-established efficacy and safety profiles, a new IV formulation of oritavancin (KIMYRSA™) has been developed, which has a shorter infusion time and a smaller infusion volume than the originally approved IV formulation (ORBACTIV ® ). The pharmacokinetic and safety profiles of oritavancin were similar between the two IV formulations. The new IV formulation of oritavancin is a convenient, effective treatment option for patients with ABSSSIs.