FDA approves Kimyrsa for faster infusion against acute bacterial skin and skin structure infections.- Melinta Therapeutics

The FDA has approved Kimyrsa (oritavancin), from Melinta Therapeutics, for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of designated Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA). The efficacy and safety of Kimyrsa were established in the SOLO clinical trials with another oritavancin product, Orbactiv. The SOLO trials were randomized, double-blind, multicenter 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 one of the largest subsets 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 approval is based on the results of 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.Kimyrsa is the first oritavancin product that is infused over one-hour, prepared from one 1,200 mg vial, and has compatibility with both 0.9% sodium chloride injection (NS) and 5% dextrose in sterile water (D5W). As an oritavancin product, Kimyrsa has three bactericidal mechanisms of action: inhibition of transpeptidation, inhibition of transglycosylation, and disruption of cell membrane integrity.