SAN FRANCISCO – The antibiotic Vibativ (telavancin) is now approved to treat patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by Staphylococcus aureus.
Vibativ should be used for the treatment of HABP/VABP only when alternative treatments are not suitable, the Food and Drug Administration said in approving the new indication.
The safety and effectiveness of Vibativ, marketed by Theravance Inc., in treating HABP/VABP were evaluated in 1,532 patients enrolled in two clinical trials. Patients were randomly assigned to receive Vibativ or vancomycin. The trials measured the percentage of patients who died from all-cause mortality within 28 days after the initiation of treatment.
Among patients presumed to test positive for S. aureus at baseline, mortality rates were comparable between the Vibativ and vancomycin treatment arms, except in the case of patients with pre-existing kidney problems, where mortality rates were higher with Vibativ.
The FDA has added information to the Vibativ’s Boxed Warning that the drug can cause new or worsening kidney problems in patients.
Diarrhea was the most common side effect identified in the clinical trials.
Vibativ was originally approved in 2009 to treat complicated skin and skin structure infections.