Telavancin is a bactericidal lipoglycopeptide for use in MRSA (Methicillin-resistant Staphylococcus aureus) or other Gram-positive infections. It is a semi-synthetic derivative of vancomycin. The FDA approved telavancin in September 2009 for complicated skin and skin structure infections.
Bacterial pneumonia, a lung infection, can be caused by several different kinds of bacteria.
Vibativ has been approved only to treat Staphylococcus aureus, not other pneumonia-causing bacteria. HABP/VABP, which is also called *nosocomial pneumonia, is an extremely dangerous hospital-acquired lung infection, because infected patients, who are often on ventilators, are usually already sick, weak and/or frail and have weakened immune systems.
*Nosocomial means acquired or originating in a hospital.
Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products, Center for Drug Evaluation and Research, FDA, said:
"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."
ATTAIN I and ATTAIN II TrialsFDA experts looked at data from two large, multi-center, multinational, double-blind, randomized Phase 3 clinical trials - ATTAIN I and ATTAIN II - involving 1,503 patients. 464 of them were infected with MRSA. Those with HABP proven or suspected to be caused by Gram-positive bacteria were randomly selected into two groups:
- The Telavancin Group - they received telavancin 10 mg/kg IV once daily
- The Vancomycin Group - they received vancomycin 1 gram IV every12 hours
The human studies measured the percentage of all-cause mortality (those who died from any cause) 28 days after treatment started.
With the exception of patients with pre-existing kidney problems, mortality rates between those in the telavancin and vancomycin groups were similar.
The FDA wrote in a communiqué yesterday "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."
The most commonly reported side effect related to Vibativ therapy in both trials was diarrhea. Vibativ is marketed by Theravance, Inc., San Francisco, California.
Rick E Winningham, Chief Executive Officer of Theravance Inc., said:
"We are excited about the approval of Vibativ for this additional indication, as it provides an important option for doctors in the treatment of patients with life-threatening hospital-acquired pneumonia caused by Staph. aureus, including MRSA.
Theravance plans to make Vibativ available for purchase through wholesalers in the third quarter of 2013 and is continuing to evaluate commercialization alternatives for the U.S. market. I would like to thank the Theravance team and the many external medical experts for their dedication in bringing this important medicine back to market."
Ralph Corey, M.D., Professor of Medicine at the Duke University Medical Center and a Principal Investigator for the Phase III Trials, said "Vibativ will be a welcome addition for physicians treating hospital-acquired bacterial pneumonia. 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. Vibativ offers effectiveness in these difficult to treat infections when alternative therapies are not suitable."
Vibativ is already approved in Europe for nosocomial pneumonia caused by MRSA - in May 2011, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for using Vibativ for the treatment of adults with nosocomial pneumonia. A few months later Vibativ was approved in Europe for that indication.
Clinigen Group plc. sells Vibativ in Europe today.