The Food and Drug Administration (FDA) has approved Kimyrsa™ (oritavancin; Melinta Therapeutics) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of designated Gram-positive microorganisms.
Kimyrsa is a single-dose, long-acting lipoglycopeptide antibiotic indicated for the treatment of ABSSSI caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible [MSSA] and -resistant [MRSA] 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).
The efficacy and safety of Kimyrsa were supported by data from the phase 3 SOLO I (ClinicalTrials.gov: NCT01252719) and II (ClinialTrials.gov: NCT01252732) trials, which compared a single dose of oritavancin 1200mg intravenously to vancomycin (1g or 15mg/kg twice daily intravenously for 7 to 10 days). Findings from both studies showed that oritavancin was as effective as vancomycin for the primary and secondary end points. Approval was also based on data from a pharmacokinetics (PK) study that compared Kimyrsa (n=50) administered over 1 hour to Orbactiv (oritavancin; Melinta) (n=52) administered over 3 hours for the treatment of adults with ABSSSI.
The most common adverse reactions reported with oritavancin products include headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea. In the PK study, hypersensitivity, pruritus, chills and pyrexia occurred in 2 or more patients receiving Kimyrsa.
“Kimyrsa was shown to be comparable to Orbactiv with a favorable safety profile,” said Michael Waters, MD, lead investigator in the PK clinical trial. “I’m pleased that these outcomes support the approval of Kimyrsa to provide oritavancin with a shorter infusion time and lower infusion volume.”
Kimyrsa is expected to be available in the summer of 2021.
Melinta Therapeutics announces FDA approval of Kimyrsa™ (oritavancin) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI). [press release]. Morristown, NJ: Melinta Therapeutics, LLC; March 15, 2021.