Telavancintelavancin, telavancin antibiotic
Telavancin trade name Vibativ is a bactericidal lipoglycopeptide for use in MRSA or other Gram-positive infections Telavancin is a semi-synthetic derivative of vancomycin
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
- 1 History
- 2 Mechanism of action
- 3 Adverse effects
- 4 Interactions
- 5 References
- 6 External links
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
The FDA approved the drug on 11 September 2009 for complicated skin and skin structure infections cSSSI
Theravance has also submitted telavancin to the FDA in a second indication, nosocomial pneumonia, sometimes referred to as hospital-acquired pneumonia, or HAP On 30 November 2012, an FDA advisory panel endorsed approval of a once-daily formulation of telavancin for nosocomial pneumonia when other alternatives are not suitable However, telavancin did not win the advisory committee's recommendation as first-line therapy for this indication The committee indicated that the trial data did not prove "substantial evidence" of telavancin's safety and efficacy in hospital-acquired pneumonia, including ventilator-associated pneumonia caused by Gram-positive organisms Staphylococcus aureus and Streptococcus pneumoniae 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
Telavancin has a higher rate of kidney failure than vancomycin in two clinical trials It showed teratogenic effects in animal studies
Telavancin inhibits the liver enzymes CYP3A4 and CYP3A5 No data regarding the clinical relevance are available
- ^ Astellas, Inc VIBATIV prescribing information, 9/2009
- ^ a b Higgins, DL; Chang, R; Debabov, DV; Leung, J; Wu, T; Krause, KM; Sandvik, E; Hubbard, JM; et al 2005 "Telavancin, a Multifunctional Lipoglycopeptide, Disrupts both Cell Wall Synthesis and Cell Membrane Integrity in Methicillin-Resistant Staphylococcus aureus" Antimicrobial Agents and Chemotherapy 49 3: 1127–1134 doi:101128/AAC4931127-11342005 PMC 549257 PMID 15728913
- ^ a b "Theravance and Astellas Announce FDA Approval of Vibativ telavancin for the Treatment of Complicated Skin and Skin Structure Infections" Press release Theravance, Inc and Astellas Pharma US, Inc 2009-09-11 Retrieved 16 September 2009
- ^ http://wwwfdagov/NewsEvents/Newsroom/PressAnnouncements/ucm358209htm
- ^ "Drugscom, FDA Accepts for Review Response to Approvable Letter for Telavancin" Retrieved 2008-03-08
- ^ 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
- ^ "wwwvibativeu, Clinigen and Theravance Announce Exclusive Commercialization Agreement in the EU for VIBATIV® telavancin" Retrieved 2014-12-09
- ^ H Spreitzer 2 February 2009 "Neue Wirkstoffe - Telavancin" Österreichische Apothekerzeitung in German 3/2009
- ^ a b c Telavancin hydrochloride Monograph
- ^ Saravolatz LD, Stein GE, Johnson LB 2009 "Telavancin: a novel lipoglycopeptide" Clinical Infectious Diseases 49 12: 1908–1914 doi:101086/648438 PMID 19911938
- Theravance, Inc
- Vibativ information
- Vibativ Europe
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