|Systematic (IUPAC) name|
|Licence data||US FDA:|
|Protein binding||90%, mostly to albumin|
|Biological half-life||9 hours|
|Excretion||76% in urine, <1% in feces|
|CAS Registry Number|
|Molecular mass||1755.63 g/mol|
The FDA approved the drug in September 2009 for complicated skin and skin structure infections (cSSSI), and in June 2013 for hospital-acquired and ventilator-associated bacterial pneumonia caused by Staphylococcus aureus.
On 19 October 2007, the US Food and Drug Administration (FDA) issued an approvable letter for telavancin. Its developer, Theravance, submitted a complete response to the letter, and the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of 21 July 2008.
On 19 November 2008, an FDA antiinfective drug advisory committee concluded that they would recommend telavancin be approved by the FDA.
Theravance has also submitted telavancin to the FDA in a second indication,  On 21 June 2013 FDA gave approval for telavancin to treat patients with hospital-acquired pneumonia, but indicated it should be used only when alternative treatments are not suitable. FDA staff had indicated telavancin has a "substantially higher risk for death" for patients with kidney problems or diabetes compared to vancomycin.
On March 11 2013, Clinigen Group plc and Theravance, Inc. announced that they have entered into an exclusive commercialization agreement in the European Union (EU) and certain other countries located in Europe for VIBATIV® (telavancin) for the treatment of nosocomial pneumonia (hospital-acquired), including ventilator-associated pneumonia, known or suspected to be caused by methicillin resistant Staphylococcus aureus (MRSA) when other alternatives are not suitable.
Mechanism of action
Like vancomycin, telavancin inhibits bacterial cell wall synthesis by binding to the D-Ala-D-Ala terminus of the peptidoglycan in the growing cell wall (see Pharmacology and chemistry of vancomycin). In addition, it disrupts bacterial membranes by depolarization.
Common but harmless adverse effects include nausea, vomiting, constipation, and headache.
- Astellas, Inc. VIBATIV prescribing information, 9/2009.
- FDA advisory group gives mixed review of Theravance pneumonia treatment. 30 Nov 2012 American City Business Journals/San Francisco/BiotechSF blog
- Leuty, Ron. Theravance gets FDA OK for antibiotic against pneumonia, with limits. San Francisco Business Times. Jun 21, 2013.
- Telavancin hydrochloride
- Theravance, Inc.
- Vibativ information
- Vibativ Europe