FDA accepts Theravance Biopharma sNDA on Vibativ

Theravance Biopharma, Inc. said Thursday that the the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for its drug Vibativ ( telavancin) to expand its label to include treatment of Staphylococcus aureus.

"Both primary bacteremia and concurrent bacteremia continue to increase in incidence and severity, and this growing health threat is compounded by the relative lack of effective treatments for these infections," Theravance Biopharma Chairman and CEO Rick Winningham said. "To address this important unmet need, we are taking a proactive approach to evaluating the potential of Vibativ in this area. This is evidenced not only by today's sNDA milestone but also our ongoing Phase 3 registrational study of telavancin in Staphylococcus aureus bacteremia. We are pleased with this action by FDA regarding the sNDA and look forward to working with the agency to help advance the goal of expanding treatment options for patients battling both primary and concurrent bacteremia."

Vibativ is an approved treatment option hospital-acquired and ventilator-associated pneumonia and for cases of complicated skin and structure infections. According to the company, bacteriemia, bacteria present in the bloodstream, is a medical need currently not being met by available medication and procedures.

Currently, Theravance Biopharma is in Phase 3 clinical trials to determine the drug's effectiveness for patients with Staphylococcus aureus infections and is expected to finish in 2017.

Organizations in this story

Theravance Biopharma 901 Gateway Boulevard South San Francisco, CA 94080

U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD 20903

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