Lipoglycopeptide

Approvals and clinical trials

Telavancin (once daily injection) has completed 4 phase III trials. and gained US FDA approval in September 2009 for complicated skin and skin structure infections (cSSSI).{{cite press release | access-date = September 16, 2009

Oritavancin (once daily injection) has completed phase II and phase III trials. Oritavancin was approved by the FDA on August 6, 2014, and by the EMA mid-2015, for treatment of acute bacterial skin and skin structure infections (ABSSSI).

Dalbavancin (once-weekly injection) The FDA approved dalbavancin for use to treat MRSA infections in adults on May 23, 2014. Dalbavancin 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, dalbavancin 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, dalbavancin was given priority review, which provides an expedited review of the drug's application. dalbavancin'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.

References

References

1. (2005). "Glycopeptide and Lipoglycopeptide Antibiotics". Chemical Reviews.
2. (1 Feb 2011). "Fight Against Antimicrobial Resistance Recruiting New Agents".
3. (2010-05-07). "New lipoglycopeptides: a comparative review of dalbavancin, oritavancin and telavancin". Drugs.
4. 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.
5. "CTG Labs - NCBI".
6. (13 August 2008). "Nuvocid® (Oritavancin) at Single or Infrequent Doses for the Treatment of Complicated Skin and Skin Structure Infections (SIMPLIFI)".
7. Kmeid J, Kanafani ZA. (2015). "Oritavancin for the treatment of acute bacterial skin and skin structure infections: an evidence-based review.". Core Evid.
8. (2018). "Single Intravenous Dose of Oritavancin for Treatment of Acute Skin and Skin Structure Infections Caused by Gram-Positive Bacteria: Summary of Safety Analysis from the Phase 3 SOLO Studies.". Antimicrob Agents Chemother.
9. "FDA approves Orbactiv to treat skin infections".
10. (17 September 2018). "Tenkasi (Previously Orbactiv)".
11. (23 June 2005). "Phase II, Randomized, Open-Label, Multi-Center Study to Evaluate the Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections with Suspected or Confirmed Gram-Positive Bacterial Pathogens".