Melinta Therapeutics, LLC (Melinta), today announced that the U.S. Food and Drug Administration (FDA) has approved KIMYRSA™ (oritavancin) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of designated Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA).
KIMYRSA is a lipoglycopeptide antibiotic that delivers a complete course of therapy for ABSSSI in a single, one hour 1,200 mg infusion.
“The approval of KIMYRSA demonstrates Melinta’s commitment to provide innovative therapies to patients with acute and life-threatening illnesses,” said Christine Ann Miller, President and Chief Executive Officer of Melinta. “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 one-dose alternative to the current standard of multi-dose regimens for ABSSSI.”
ABSSSI affect approximately 14 million patients in the U.S. each year, are responsible for over 3 million visits to the Emergency Room annually and represent the 8th most common cause of Emergency Department hospital admissions. ABSSSI cost U.S. hospitals $4 billion each year, with a 4.1-day average length of stay for hospitalized ABSSSI patients.
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