Melinta's Kimyrsa (oritavancin) Receives the US FDA's Approval for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Shots:
- The approval is based on P-III SOLO trial involves assessing the safety- efficacy- and PK of Kimyrsa (qd- 1200 mg- IV dose- over 1 hour) vs vancomycin (1gm or 15 mg/kg- bid- over 3 hours) in 1-987 adults with ABSSSI
- The 1EP and 2EP of the trial demonstrated that shorter infusion time and lower infusion volume of Kimyrsa is as effective as 7-to-10 days twice-daily vancomycin
- Kimyrsa is a long-acting lipoglycopeptide antibiotic with rapid bactericidal activity for the treatment of adult patients with ABSSI caused by designated Gram-positive microorganisms- including MRSA and is expected to be available in the US in 2021
Ref: Business Wire | Image: Business Wire
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