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The single-dose antibiotic with a one-hour infusion is approved to treat MRSA and other skin infections.
Melinta Therapeutics has launched Kimyrsa (oritavancin), a lipoglycopeptide antibiotic to treat acute bacterial skin and skin structure infections (ABSSSI) in a single, one hour, 1,200 mg infusion.
The FDA had approved Kimyrsa in March 2021, for the treatment of adult patients with ABSSSI caused by susceptible isolates of designated Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA). The most common adverse reactions (≥3%) in patients treated with oritavancin products were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea.
“Kimyrsa is a direct response to the requests of the medical community to provide an oritavancin product with a shorter infusion time, additional diluent options, and lower infusion volume,” John Harlow, chief commercial officer of Melinta said in a statement.
The company already markets Orbactiv, a oritavancin that was approved in 2014 and has a three-hour infusion time.
ABSSSIs affect about 14 million patients in the United States each year and are responsible for more than 3 million visits to the emergency room annually, according to press release issued by Melinta.
An increase in MRSA skin infections has been a major contributor to the U.S. burden of skin infections. In one study, investigators found that the rate of clinically-diagnosed skin and soft tissue infections was 496 per 10,000 person-years, with MRSA infections being 46% of the Staphylococcus aureus infections that were cultured.
Treatment of ABSSSI is not straightforward, and poor outcomes are characterized by spreading infection, bacteremia, septic shock, osteomyelitis, recurrence, prolonged hospitalization, or death.