The U.S. Food and Drug Administration today expanded the approved
use of the antibiotic Vibativ (telavancin) 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.
Bacterial pneumonia is a lung infection
that can be caused by many different types of bacteria. Vibativ is
approved only to treat S. aureus, not other bacteria that cause
pneumonia. 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.
“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,” said Edward Cox, M.D., M.P.H, director of the Office of
Antimicrobial Products in the FDA’s Center for Drug Evaluation and
Research.
Vibativ’s safety and effectiveness to
treat HABP/VABP were evaluated in 1,532 patients enrolled in two
clinical trials. Patients were randomly assigned to receive Vibativ or
vancomycin, another antibiotic approved by the FDA.
The
trials measured the percentage of patients who died from any cause
(all-cause mortality) 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 Vibativ 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 Vibativ died compared to
those treated with vancomycin. Vibativ 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.
Vibativ
was approved in 2009 to treat complicated skin and skin structure
infections. It is marketed by Theravance, Inc., based in San Francisco,
Calif. (Excerpt from USFDA)
