Theravance, Astellas Report FDA Approval Of Vibativ

Theravance and Astellas have reported that the FDA has approved Vibativ (telavancin) for the treatment of adult patients with complicated skin and skin structure infections (cSSSI).

Vibativ is a bactericidal, once-daily injectable lipoglycopeptide antibiotic discovered by Theravance.

Vibativ will be marketed and sold by Astellas and is expected to be commercially available in the US during the fourth quarter of 2009.

Reportedly, Theravance will collaborate with Astellas for marketing in the US for the first three years, following approval.

Rick Winningham, CEO at Theravance, said: “We are very pleased with the FDA’s approval of Vibativ, and extremely excited about the prospect of bringing this new medicine to the market 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.”