FDA approves Kimyrsa to treat acute bacterial skin and skin structure infections (ABSSSI).- Melinta Therapeutics

Melinta Therapeutics, LLC announced that the FDA has approved Kimyrsa (oritavancin) 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). Kimyrsa is a lipoglycopeptide antibiotic that delivers a complete course of therapy for ABSSSI in a single, one hour 1,200 mg infusion. A compelling new one-dose alternative to the current standard of multi-dose regimens for ABSSSI. 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 a next-gen version of Melinta's Orbactiv antibiotic and has been tested both head-to-head against the commonly used antibiotic vancomycin and alongside its predecessor. A long-acting lipoglycopeptide antibiotic Kimyrsa is given as a one-hour, 1,200-mg infusion, potentially offering clinicians flexibility to treat patients outside the hospital. The FDA approved the drug based on results from an open-label pharmacokinetics study that compared an hour-long Kimyrsa infusion with a three-hour Orbactiv infusion. In SOLO trial, researchers compared a single, 1,200mg intravenous dose of Kimyrsa against twice-daily vancomycin in 1,987 adults, including a subset of 405 patients with methicillin-resistant Staphylococcus aureus infection,. A single Kimyrsa dose was as effective as 7-10 days of twice-daily vancomycin at 15mg/kg.