FDA advisory committee recommends approval of Sivextro for ABSSSI - Cubist

The FDA Anti-Infective Drugs Advisory Committee (AIDAC) voted to recommend approval of Cubist�s investigational antibiotic Sivextro (tedizolid phosphate), from Cubist Pharma, for the treatment of acute bacterial skin and skin structure infections (ABSSSI). In the unanimous 14 - 0 decision, the AIDAC found that substantial evidence of the safety and effectiveness of Sivextro for ABSSSI was provided.

Two Phase III studies, conducted in the US, Europe and other regions worldwide, in ABSSSI and cSSTI demonstrated that tedizolid 200 mg once daily for six days was statistically non-inferior to 10 days of linezolid 600 mg twice daily for the primary efficacy endpoints. Secondary endpoints were also met. In these studies, the adverse event rates were similar for both tedizolid and linezolid treated patients. Gastrointestinal adverse events (diarrhea, nausea and vomiting) were the most commonly reported in both treatment groups. A decision from the European Commission (EC) is expected during the first half of 2015.