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.
For more information call (877) 275-8479 or visit www.theravance.com.