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Theravance (THRX) reports outcome of the FDA Advisory Committee

Theravance (THRX) reports outcome of the FDA Advisory Committee meeting on VIBATIV (telavancin) for the treatment of nosocomial pneumonia (stock halted) (THRX) 21.40 +0.00 : Co announced the outcome of the Anti-Infective Drugs Advisory Committee (AIDAC) of the FDA meeting on VIBATIV (telavancin) for the treatment of nosocomial pneumonia (NP) due to susceptible isolates of Gram-positive microorganisms.

The committee was asked to consider the totality of data presented including analyses of clinical cure and 28-day all-cause mortality. The committee voted 6 (yes) and 9 (no) that the results provide substantial evidence of the safety and effectiveness of VIBATIV for the requested indication of the treatment of NP, including ventilator-associated pneumonia, caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (both methicillin-susceptible and -resistant) and Streptococcus pneumoniae. The committee voted 13 (yes) and 2 (no) that the results provide substantial evidence of the safety and effectiveness of VIBATIV for the treatment of NP when other alternatives are not suitable.

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