FDA Advisory Committee gives restricted recommendation for Vibativ (Theravance) for Nosocomial Pneumonia
The Advisory Committee (AIDAC) of the FDA has voted 9-6 that data, from Theravance relative to Vibativ (telavancin), failed to provide substantial evidence of the safety and effectiveness of Vibativ in treating Nosocomial Pneumonia (NP) including ventilator-associated pneumonia, caused by the susceptible Gram-positive microorganisms Staphylococcus aureus, including methicillin-resistant isolates (MRSA), and Streptococcus pneumoniae.
However in a 13-2 vote, the AIDAC found the results of two Phase III studies provided substantial evidence of the safety and effectiveness of Vibativ as a treatment for NP when other alternatives are not suitable.
The drug may be restricted to NP caused by MRSA and not used in disease caused by S pneumoniae or methicillin-sensitive S aureus (MSSA).
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