|Mol. mass||1755.634 g/mol|
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Dalbavancin (INN, trade name Dalvance) is a novel second-generation lipoglycopeptide antibiotic. It belongs to the same class as vancomycin, the most widely used and one of the few treatments available to patients infected with methicillin-resistant Staphylococcus aureus (MRSA).
It possesses in vitro activity against a variety of Gram-positive pathogens including MRSA and methicillin-resistant Staphylococcus epidermidis (MRSE). It is a once-weekly, two-dose antibiotic, the rights to which Pfizer acquired when it bought Vicuron Pharmaceuticals in 2005.
The Food and Drug Administration approved dalbavancin in May 2014 for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by certain susceptible bacteria such as Staphylococcus aureus including methicillin-susceptible and methicillin-resistant strains of Streptococcus pyogenes, in intravenous dosage form.
Dalbavancin has undergone a phase-III clinical trial for adults with complicated skin infections, but in December 2007, the FDA said more data were needed before approval. On September 9, 2008, Pfizer announced it will withdraw all marketing applications to conduct another phase-III clinical trial. Durata Therapeutics acquired the rights to dalbavancin in December 2009, and has initiated two new phase-III clinical trials for treatment of ABSSSIs. Preliminary results in 2012 were promising.
About 1,289 adults with ABSSSI were given dalbavancin or vancomycin randomly, and dalbavancin was found to exhibit efficacy comparable to vancomycin.
In May 2014, dalbavancin was approved by the FDA for use in the US for ABSSSIs, including MRSA and Streptococcus pyogenes infections.
- Vicuron Pharmaceuticals Submits New Drug Application for Dalbavancin to U.S. Food and Drug Administration
- Scheinfeld NS. (May 2006). "Dalbavancin: A review for dermatologists.". Dermatology Online Journal 12 (6). PMID 17083861.
- Chen AY, Zervos MJ, Vazquez JA (2007). "Dalbavancin: a novel antimicrobial". Int. J. Clin. Pract. 61 (5): 853–63. doi:10.1111/j.1742-1241.2007.01318.x. PMC 1890846. PMID 17362476.
- Das B, Sarkar C, Biswas R, Pandey S (2008). "Review: dalbavancin-a novel lipoglycopeptide antimicrobial for gram positive pathogens". Pak J Pharm Sci 21 (1): 78–88. PMID 18166524.
- Dalbavancin: A Novel Lipoglycopeptide Antibacterial
- UPDATE 1-Pfizer says US FDA wants more data on antibiotic. Dec 2007
- US FDA approves drug Dalvance containing Dalbavancin
- "Pfizer Will Withdraw Global Marketing Applications for Dalbavancin to Conduct a New Trial" (Press release). Pfizer Inc. 2008-09-09. Retrieved 2008-09-11.
- Durata Begins Dalbavancin Study Enrollment. Drug Discovery & Development - October 05, 2011.
- Durata Therapeutics Announces Phase 3 Clinical Trial Results for Dalbavancin in the Treatment of ABSSSI
- Dalvance’s safety and efficacy clinical trial ABSSSI, Results showed Dalvance was as effective as vancomycin