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US FDA clears Theravance Vibativ for hospital-acquired, ventilator-associated bacterial pneumonia

PBR Staff Writer Published 24 June 2013

The US Food and Drug Administration (FDA) has cleared Theravance's Vibativ (telavancin) for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).

With a dual mechanism of action, the bactericidal, once-daily, injectable lipoglycopeptide antibiotic inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function.

The product is indicated for HABP/VABP treatment, caused by susceptible isolates of Staphylococcus aureus, when no other treatment seems appropriate.

Theravance chief executive officer Rick Winningham said that the additional indication of Vibativ provides an important option for doctors in the treatment of patients with life-threatening hospital-acquired pneumonia caused by Staph. aureus, including MRSA.

"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," Winningham added.

Vibativ is also approved for cSSSI caused by susceptible isolates of Gram-positive bacteria, including Staphylococcus aureus, both methicillin-susceptible and methicillin-resistant strains.