FDA approves Melinta's Kimyrsa for skin infections Melinta Therapeutics of Morristown, New Jersey, announced yesterday that the US Food and Drug Administration (FDA) has approved Kimyrsa (oritavancin) for treatment of adult patients with acute bacterial skin and skin-structure infections (ABSSSIs) caused by susceptible gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA). Kimyrsa delivers a complete course of the lipoglycopeptide antibiotic oritavancin in a single, 1-hour 1,200 milligram (mg) intravenous infusion. The drug is an updated version of Orbactiv, which was approved by the FDA in 2014 for treatment of ABSSSIs and is infused over 3 hours. The safety and efficacy of Kimyrsa was previously established in randomized clinical trials that showed that a single 1,200 mg infusion of Orbactiv was as effective 7 to 10 days of twice daily vancomycin in treating 1,987 ABSSSI patients, including 405 with documented MRSA infection. FDA approval was based on a pharmacokinetics study that showed the safety profile was favorable to Orbactiv.