Telavancin

Telavancin
Clinical data
Trade names Vibativ
AHFS/Drugs.com Monograph
MedlinePlus a610004
License data
Pregnancy
category
  • US: C (Risk not ruled out)
    Routes of
    administration
    intravenous
    ATC code
    Legal status
    Legal status
    Pharmacokinetic data
    Bioavailability N/A
    Protein binding 90%, mostly to albumin
    Elimination half-life 9 hours
    Excretion 76% in urine, <1% in feces
    Identifiers
    CAS Number
    PubChem CID
    ChemSpider
    UNII
    ChEBI
    ChEMBL
    Chemical and physical data
    Formula C80H106Cl2N11O27P
    Molar mass 1755.63 g/mol
    3D model (JSmol)
     NY (what is this?)  (verify)

    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.[1][2]

    The FDA approved the drug in September 2009 for complicated skin and skin structure infections (cSSSI),[3] and in June 2013 for hospital-acquired and ventilator-associated bacterial pneumonia caused by Staphylococcus aureus.[4]

    History

    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.[5]

    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).[3]

    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.[6] 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.[7]

    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.[8]

    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.[2][9]

    Adverse effects

    Common but harmless adverse effects include nausea, vomiting, constipation, and headache.[10]

    Telavancin has a higher rate of kidney failure than vancomycin in two clinical trials.[11] It showed teratogenic effects in animal studies.[10]

    Interactions

    Telavancin inhibits the liver enzymes CYP3A4 and CYP3A5. No data regarding the clinical relevance are available.[10]

    References

    1. Astellas, Inc. VIBATIV prescribing information, 9/2009.
    2. 1 2 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:10.1128/AAC.49.3.1127-1134.2005. PMC 549257. PMID 15728913. Archived from the original on 2009-10-02.
    3. 1 2 "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. Archived from the original on 22 September 2009. Retrieved 16 September 2009.
    4. "Archived copy". Archived from the original on 2013-08-31. Retrieved 2013-08-19.
    5. "Drugs.com, FDA Accepts for Review Response to Approvable Letter for Telavancin". Archived from the original on 2008-03-09. Retrieved 2008-03-08.
    6. FDA advisory group gives mixed review of Theravance pneumonia treatment. 30 Nov 2012 Archived 2012-12-04 at the Wayback Machine. American City Business Journals/San Francisco/BiotechSF blog
    7. Leuty, Ron. Theravance gets FDA OK for antibiotic against pneumonia, with limits. Archived 2013-06-23 at the Wayback Machine. San Francisco Business Times. Jun 21, 2013.
    8. "www.vibativ.eu, Clinigen and Theravance Announce Exclusive Commercialization Agreement in the EU for VIBATIV® (telavancin)". Archived from the original on 2014-09-13. Retrieved 2014-12-09.
    9. H. Spreitzer (2 February 2009). "Neue Wirkstoffe - Telavancin". Österreichische Apothekerzeitung (in German) (3/2009).
    10. 1 2 3 Telavancin hydrochloride Monograph
    11. Saravolatz LD, Stein GE, Johnson LB (2009). "Telavancin: a novel lipoglycopeptide". Clinical Infectious Diseases. 49 (12): 1908–1914. doi:10.1086/648438. PMID 19911938.
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