Lipoglycopeptide

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Lipoglycopeptides are a class of antibiotic that have lipophilic side-chains linked to glycopeptides. The class includes oritavancin, telavancin and dalbavancin.[1] [2]

Telavancin is the only one that has FDA approval.

Telavancin is the most potent of the 3 against Clostridium spp.[3]

Approvals and clinical trials[edit]

Telavancin (once daily injection)[4] has completed 4 phase III trials.[5] and gained US FDA approval in September 2009 for complicated skin and skin structure infections (cSSSI).[6]

Oritavancin (once daily injection)[4] has completed a phase II trial. [7] As of September 2010 it doesn't have US or European approval for marketing for clinical use. (In December 2008 the FDA declined to approve it, and an EU application was withdrawn.) Oritavancin was approved by the FDA on August 6th, 2014 for treatment of acute bacterial skin and skin structure infections (ABSSSI). [8]

Dalbavancin (once-weekly injection)[4] was undergoing a phase II trial, due to end in 2003.[9] The FDA approved Dalbavancin for use to treat MRSA infections in adults on May 23rd, 2014. Dalbavancin (Dalvance) is intended to treat acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes. Dalbavancin is the first drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, Dalvance was granted QIDP designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections. As part of its QIDP designation, Dalvance was given priority review, which provides an expedited review of the drug’s application. Dalvance’s QIDP designation also qualifies it for an additional five years of marketing exclusivity to be added to certain exclusivity periods already provided by the Food, Drug and Cosmetic Act.

See also[edit]

References[edit]

  1. ^ Kahne, Dan; Leimkuhler, Catherine; Lu, Wei; Walsh, Christopher (2005). "Glycopeptide and Lipoglycopeptide Antibiotics". Chemical Reviews 105 (2): 425–448. doi:10.1021/cr030103a. PMID 15700951. 
  2. ^ "Fight Against Antimicrobial Resistance Recruiting New Agents". 1 Feb 2011. 
  3. ^ Zhanel, George G.; Calic, Divna; Schweizer, Frank; Zelenitsky, Sheryl; Adam, Heather; Lagacé-Wiens, Philippe R.S.; Rubinstein, Ethan; Gin, Alfred S. et al. (2010-05-07). "New lipoglycopeptides: a comparative review of dalbavancin, oritavancin and telavancin". Drugs 70 (7): 859–886. doi:10.2165/11534440-000000000-00000. PMID 20426497. 
  4. ^ a b c Van Bambeke F. (August 2006). "Glycopeptides and glycodepsipeptides in clinical development: a comparative review of their antibacterial spectrum, pharmacokinetics and clinical efficacy,". Curr Opin Investig Drugs. 7 (8): 740–9. PMID 16955686. 
  5. ^ http://clinicaltrials.gov/ct2/results?term=telavancin&phase=2
  6. ^ "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 September 16, 2009. 
  7. ^ http://clinicaltrials.gov/ct2/show/NCT00514527
  8. ^ http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm408475.htm
  9. ^ http://clinicaltrials.gov/ct2/show/NCT00057369