FDA approves Vibativ for hospitalized patients with bacterial pneumonia

FDA has expanded the use of telavancin (Vibativ, Theravance) to treat 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.

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 [expanded approval] demonstrates the willingness of FDA to evaluate the safety and efficacy of drugs that can be used in critically ill patients and in addition affords prescribers with the opportunity to offer alternative therapeutic interventions to their patients if one or more fail to achieve a desirable clinical outcome,” said Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, Webster, Texas.

FDA approved telavancin in 2009 for treating complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of Gram-positive bacteria, including S. aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains.

"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," said Ralph Corey, MD, 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, in a company press release.

Telavancin’s safety and effectiveness to treat HABP/VABP were evaluated in 1,532 patients enrolled in 2 clinical trials. Patients were randomly assigned to receive telavancin or vancomycin, another antibiotic approved by FDA.

The trials measured the percentage of patients who died from any cause 28 days after the initiation of treatment. Among patients presumed to test positive for S. aureus taken at baseline, mortality rates were comparable between the telavancin and vancomycin treatment arms, except for patients who had pre-existing kidney problems.

During clinical trials, more patients with pre-existing kidney problems treated with telavancin died compared to those treated with vancomycin. Telavancin can also cause new or worsening kidney problems in patients. This information has been added to Vibativ’s Boxed Warning.

Diarrhea was the most common side effect identified in the clinical trials.