Telavancin
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| Clinical data | |
| Trade names | Vibativ |
| AHFS/Drugs.com | monograph |
| MedlinePlus | a610004 |
| Licence data | US FDA:link |
| Pregnancy cat. | C (US) |
| Legal status | ℞-only (US) |
| Routes | intravenous |
| Pharmacokinetic data | |
| Bioavailability | N/A |
| Half-life | 9 hours |
| Identifiers | |
| CAS number | 372151-71-8  |
| ATC code | J01XA03 |
| PubChem | CID 3081362 |
| ChemSpider | 2338980  |
| UNII | XK134822Z0 |
| ChEMBL | CHEMBL607993 |
| Chemical data | |
| Formula | C80H106Cl2N11O27P |
| Mol. mass | 1755.63 |
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Telavancin (trade name Vibativ) is a bactericidal lipoglycopeptide for use in MRSA or other Gram-positive infections. Telavancin is a synthetic derivative of vancomycin.[1][2]
The FDA approved the drug in September 2009 for complicated skin and skin structure infections (cSSSI).[3]
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[edit] 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.[4]
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 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. The PDUFA goal date for this indication is 26 November 2009.
[edit] Mechanism of action
Like vancomycin, telavancin inhibits bacterial cell wall synthesis (see Pharmacology and chemistry of vancomycin). In addition, it disrupts bacterial membranes by depolarization.[2][5]
[edit] Adverse effects
Telavancin has a higher rate of kidney failure than vancomycin in two clinical trials.[6] It showed teratogenic effects in animal studies.
[edit] References
- ^ 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:10.1128/AAC.49.3.1127-1134.2005. PMC 549257. PMID 15728913. http://aac.asm.org/cgi/content/full/49/3/1127.
- ^ 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. http://www.drugs.com/newdrugs/theravance-astellas-announce-fda-approval-vibativ-telavancin-complicated-skin-skin-structure-1629.html. Retrieved 16 September 2009.
- ^ "Drugs.com, FDA Accepts for Review Response to Approvable Letter for Telavancin". http://www.drugs.com/nda/telavancin_080306.html. Retrieved 2008-03-08.
- ^ H. Spreitzer (2 February 2009). "Neue Wirkstoffe - Telavancin" (in German). Österreichische Apothekerzeitung (3/2009).
- ^ Saravolatz LD, Stein GE, Leonard B. Johnson LB. "Telavancin: a novel lipoglycopeptide". Clinical Infectious Diseases 49 (12): 1908–1914. doi:10.1086/648438.
[edit] External links
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