US FDA extends approval of Theravance’s lung drug

The US Food and Drug Administration has approved Theravance's Vibativ 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.

Bacterial pneumonia is a lung infection that can be caused by many different types of bacteria. HABP/VABP, also known as nosocomial pneumonia, is a particularly serious lung infection because patients in the hospital and especially those on ventilators are often already very sick and usually cannot fight the infection.

Vibativ (telavancin) 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.

The US FDA approved Vibativ back in 2009 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. 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."

Rick E Winningham, Theravance'sChief Executive Officer.

Clinical trials of 1,532 patients evaluated Vibativ's safety and effectiveness to treat HABP/VABP.

"Today's approval demonstrates the FDA's commitment to making available new therapeutic options to treat serious diseases like HABP/VABP, particularly for very ill patients who have exhausted or cannot take other available treatments."

Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.