Theravance Faces Prospect Of Another Trial For Vibativ In Hospital-Acquired Pneumonia
This article was originally published in The Pink Sheet Daily
FDA says if it accepts pooling of mortality data from the drug's two nosocomial pneumonia studies, they would be considered a single trial.
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Theravance has received two complete response letters but says it does not plan to do additional clinical studies for the new indication; Vibativ production has been halted in the U.S. and its marketing authorization withdrawn in Europe.
A Risk Evaluation and Mitigation Strategy that addresses the teratogenicity of Theravance’s Vibativ enabled FDA to manage an internal disagreement that pitted the drug’s risk to the unborn against the public health need for new antibiotics.
A fierce dispute between researchers and clinicians who think community-acquired bacterial pneumonia drugs should be evaluated by their effect on mortality, and those who favor symptom-based evaluation, is unlikely to be quelled by actions taken at the Dec. 9 meeting of FDA's Anti-Infective Drugs Advisory Committee, which gave each side some of what it wanted