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FDA Approves ABSSSI Treatment

Melinta Therapeutics’ oritavancin therapy is indicated for treatment of acute bacterial skin and skin structure infections (ABSSSI) in adult patients.

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.