Vibativ approved for complicated skin and skin structure infections
VIBATIV (telavancin) 250mg, 750mg single dose vial injection from Theravance and Astellas
The FDA has approved Vibativ (telavancin, from Theravance and Astellas), a bactericidal, once-daily injectable lipoglycopeptide antibiotic. Vibativ is indicated for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains. This approval was based on results from two large, Phase 3, multinational, double-blind clinical studies, ATLAS I and ATLAS II, that compared the efficacy and safety of Vibativ to vancomycin in 1,867 adult patients with CSSSI caused by gram-positive bacteria, 719 of whom had infections with MRSA. In both studies, Vibativ achieved its primary endpoint of non-inferiority relative to vancomycin.
Vibativ is expected to be available in the fourth quarter of 2009.