March 15, 2021
The U.S. FDA has approved Kimyrsa™ (oritavancin), manufactured by Melinta Therapeutics, to treat adults who have acute bacterial skin and skin structure infection (ABSSSI) caused by susceptible isolates of designated gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA).
Approximately 14 million people in the U.S. are diagnosed with an ABSSSI each year. Although these infections are often treated with vancomycin, some organisms responsible for ABSSSIs have developed resistance to this antibiotic over time. Kimyrsa provides an additional treatment option that targets gram- positive organisms, meaning it works against bacteria that have a certain type of cell wall.
In clinical trials, a single dose of oritavancin, the active pharmaceutical ingredient (API) in Kimyrsa, was as effective as 7 to 10 days of treatment with twice-daily vancomycin.
Kimyrsa is a follow-on product for Melinta’s Orbactiv® (oritavancin). Although both medications have the same API, Orbactiv requires a three-hour intravenous (IV) infusion for administration. The recommended dosing for Kimyrsa is 1,200mg delivered as a one-time IV infusion over the course of one hour. To reduce the development of drug-resistant bacteria and maintain oritavancin’s effectiveness, Kimyrsa and Orbactiv should only be used to treat or prevent infections proven or strongly suspected to be caused by susceptible bacteria.
Melinta plans to launch Kimyrsa in the summer of 2021. Pricing information is not yet available.