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.
Clinical trials of 1,532 patients evaluated Vibativ's safety and effectiveness to treat HABP/VABP.
FDA approves Theravance's lung drug for wider use (Reuters)