Sivextro approved for hard-to-treat skin infections
- FDA has approved Sivextro (tedizolid phosphate), an antibacterial drug, for the treatment of skin infections in adults.
- Sivextro, which is marketed by Massachusetts-based Cubist Pharmaceuticals, is for treatment of a specific type of skin infection---acute bacterial skin and skin structure infections (ABSSSI).
- Sivextro is the second antibacterial drug for the treatment of ABSSSI approved by FDA within the last month.
Sivextro becomes the second drug to be approved under the FDA's Qualified Infectious Disease Product (QIDP) designation, a new designation for antibacterial or antifungal human drugs developed for the treatment of serious or life-threatening infections. The first was Dalvance (dalbavancin), which was approved on May 23.
Clinical trials of Sivextro involved 1,315 adults with ABSSSI randomly assigned to either Sivextro or linezolid. In trials, Sivextro was as effective as linezolid. The approval covers use of Sivextro for Staphylococcus aureus (SA), including methicillin-resistant SA (MRSA), various Streptococcus species and Enterococcus faecalis. Given the tremendous challenge of resistance, the advent of two new antibacterials is a positive development in the treatment of ABSSSIs.
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