US FDA approves Theravance and Astellas' Vibativ

US firm Theravance and Astellas Pharma US, a subsidiary of the Japanese drug major, says that the Food and Drug Administration has approved Vibativ (telavancin) 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. VIBATIV is a bactericidal, once-daily injectable lipoglycopeptide antibiotic discovered by Theravance.

Commenting on the news, Rick Winningham, Theravance's chief executive, said:"This is a significant event that marks the first approved indication for Vibativ and validates Theravance's strategies in drug discovery and development. We believe that Vibativ will become an important medicine addressing the urgent medical need for new antibiotics to treat Gram-positive infections caused by MRSA."

"VIBATIV has demonstrated its efficacy and safety in clinical trials for the treatment of Gram-positive complicated skin and skin structure infections which included the largest cohort of patients with methicillin-resistant Staphylococcus aureus studied to date," said Ralph Corey, Professor of Medicine at the Duke University Medical Center and the principal investigator in the ATLAS program. "

VIBATIV will be marketed and sold by Astellas and is expected to be commercially available in the USAS during the fourth quarter of 2009. Theravance will collaborate with Astellas in marketing there for the first three years following approval.