FDA Approves Vibativ for Hospitalized Patients with Bacterial Pneumonia
June 21, 2013 -- 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.
Posted: June 2013
- Theravance Biopharma Announces FDA Approval of Expanded Label for Vibativ (telavancin) - May 9, 2016
- Theravance and Astellas Announce FDA Approval of Vibativ (telavancin) for the Treatment of Complicated Skin and Skin Structure Infections - September 13, 2009
- FDA Accepts for Review Theravance's Complete Response Submission for Telavancin for the Treatment of Complicated Skin and Skin Structure Infections - April 25, 2009
- Theravance Announces FDA Acceptance of Telavancin NDA for the Treatment of Hospital-Acquired Pneumonia - April 7, 2009
- Theravance Receives Complete Response Letter on the Telavancin New Drug Application for the Treatment of cSSSI - February 27, 2009
- Theravance Submits U.S. NDA for Telavancin for the Treatment of Hospital-Acquired Pneumonia - January 27, 2009
- Theravance Reports Favorable Outcome of FDA Advisory Committee Meeting on Telavancin for the Treatment of Complicated Skin and Skin Structure Infections - November 20, 2008
- FDA Accepts for Review Theravance's Complete Response to Approvable Letter for Telavancin for the Treatment of Complicated Skin and Skin Structure Infections - March 6, 2008
- Theravance Receives Notice of Possible Telavancin Review by FDA Advisory Committee - January 2, 2008
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