FDA approval of VIBATIV(R) (telavancin) for the treatment of bacterial pneumonia
Theravance, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved VIBATIV® (telavancin) for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus when alternative treatments are not suitable. VIBATIV®, discovered and developed by Theravance, is a bactericidal, once-daily, injectable lipoglycopeptide antibiotic with a dual mechanism of action whereby telavancin both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. In 2009, VIBATIV® was approved in the U.S. for the treatment of complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including Staphylococcus aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains.
“We are excited about the approval of VIBATIV® for this additional indication, as it provides an important option for doctors in the treatment of patients with life-threatening hospital-acquired pneumonia caused by Staph. aureus, including MRSA,” said Rick E Winningham, Theravance’s Chief Executive Officer. “Theravance plans to make VIBATIV® available for purchase through wholesalers in the third quarter of 2013 and is continuing to evaluate commercialization alternatives for the U.S. market. I would like to thank the Theravance team and the many external medical experts for their dedication in bringing this important medicine back to market.”
“VIBATIV® will be a welcome addition for physicians treating hospital-acquired bacterial pneumonia,” said Ralph Corey, M.D., Professor of Medicine at the Duke University Medical Center and a Principal Investigator for the studies that evaluated the safety and efficacy of VIBATIV® in HABP/VABP. “Pneumonia is associated with one of the highest mortality rates among hospital-acquired infections and increases hospital stay and costs of care. MRSA pneumonia, in particular, is an increasingly challenging infection as there are few approved treatments available today and resistance to current antibiotics remains a problem. VIBATIV® offers effectiveness in these difficult to treat infections when alternative therapies are not suitable.”