The FDA wants more data on Theravance's Vibativ (telavancin) before it will approve the treatment for nosocomial pneumonia. The agency suggested a design for any new trials, which means getting the data necessary for approval could require additional trials of the drug.
The FDA had this to say about Theravance's data: "While we acknowledge that additional mortality data and analyses have been provided to support pooling the two Phase III clinical trials, even if this is acceptable, the two pooled studies would equate to only one adequate and well-controlled trial and would not constitute substantial evidence of efficacy. The adequacy and similarity of populations across studies for the purposes of pooling has not yet been determined, and is a review issue.'
Vibativ won approval in September for treatment of MRSA-related skin infections. The company's CEO Rick Winningham notes in a statement that it is not yet clear what additional data the FDA will require for approval.
- take a look at Theravance's release
- here's a BusinessWeek article for more