FDA Approves ABSSSI Treatment

The Food and Drug Administration (FDA) announced on Monday it had approved Melinta Therapeutics’ oritavancin (Kimyrsa) to treat ABSSSI caused by susceptible isolates of designated Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA).

“We have responded to the requests of the medical community to provide an oritavancin product with a shorter infusion time. We believe that with the approval of Kimyrsa and product availability this summer, physicians and patients will now have a compelling new 1-dose alternative to the current standard of multi-dose regimens for ABSSSI,” Melinta President and Chief Executive Officer Christine Ann Miller, said.

The therapy is a long-acting lipoglycopeptide antibiotic that is indicated for a single, 1 hour 1200 mg infusion. Oritavancin has 3 bactericidal mechanisms of action: inhibition of transpeptidation, inhibition of transglycosylation, and disruption of cell membrane integrity.

The therapy’s FDA approval was based on the results of an open-label, multi-center, pharmacokinetics study, which compared Kimyrsa administered over 1 hour (N=50) to another oritavancin product, Orbactiv, administered over 3 hours (N=52) for ABSSSI treatment in adult patients.

The company stated oritavancin’s efficacy and safety were established in the SOLO clinical trials with Orbactiv. These trials were randomized, double-blind, multicenter studies that evaluated a single 1200 mg IV dose of oritavancin against twice-daily vancomycin for the treatment of ABSSSI in 1987 adult patients and assessed one of the largest subsets of documented MRSA infection (405 patients).

The company is planning a launch of the therapy in the summer of 2021.