logo
  

Theravance Reports Favorable Outcome Of FDA Committee Meeting On Vibativ

Theravance Inc. (THRX) announced a favorable outcome of the Anti-Infective Drugs Advisory Committee or AIDAC of the U.S. Food and Drug Administration or FDA meeting on Vibativ (telavancin) for the treatment of nosocomial pneumonia or NP due to susceptible isolates of Gram-positive microorganisms.

"We are pleased that the advisory committee believes there is a role for VIBATIV in the treatment of nosocomial pneumonia, a serious disease that causes significant morbidity and mortality, particularly given rising microbial resistance to existing therapies," said Rick Winningham, Chief Executive Officer of Theravance.

The company said that 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.

Vibativ, a bactericidal, once-daily, injectable lipoglycopeptide antibiotic, was discovered by Theravance in a research program dedicated to finding new antibiotics for serious infections due to Staphylococcus aureus and other Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus.

For comments and feedback contact: editorial@rttnews.com

Follow RTT