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Dalbavancin (INN, trade names Dalvance in the US and Xydalba in Europe) 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).〔(Vicuron Pharmaceuticals Submits New Drug Application for Dalbavancin to U.S. Food and Drug Administration )〕 Dalbavancin is a semisynthetic lipoglycopeptide that was designed to improve upon the natural glycopeptides currently available, vancomycin and teicoplanin. It possesses ''in vitro'' activity against a variety of Gram-positive pathogens including MRSA and methicillin-resistant ''Staphylococcus epidermidis'' (MRSE).〔( Dalbavancin: A Novel Lipoglycopeptide Antibacterial )〕 It is a once-weekly, two-dose antibiotic, the rights to which Actavis acquired when it bought Durata Therapeutics in 2014.〔( UPDATE 1-Pfizer says US FDA wants more data on antibiotic. Dec 2007 )〕 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.〔(US FDA approves drug Dalvance containing Dalbavancin )〕 ==Medical uses== Dalbavancin is an antibiotic used to treat acute bacterial skin and skin structure infections (ABSSSI) in adults caused by susceptible Gram-positive organisms, including methicillin-resistant ''Staphylococcus aureus'' (MRSA). MRSA infections have become problematic in the community and in healthcare settings due to resistance to many available antibiotics.〔 Centers for Disease Control and Prevention - Methicillin-Resistant ''Staphylococcus aureus'' (MRSA) infections. http://www.cdc.gov/mrsa/〕 Because dalbavancin has demonstrated efficacy against MRSA and other microorganisms to treat serious or life-threatening infections, it was the first drug approved as a Qualified Infectious Disease Product under the Generating Antibiotic Incentives Now (GAIN) act, which is part of the FDA Safety and Innovation Act.〔Dalbavancin: First I.V. antibiotic for acute bacterial skin infections. http://www.pharmacist.com/dalbavancin-first-iv-antibiotic-acute-bacterial-skin-infections〕 It has strong activity against many Gram-positive bacteria, including methicillin-sensitive and methicillin-resistant ''Staphylococcus aureus'', ''Streptococcus pyogenes'', ''Streptococcus agalactiae'', ''Streptococcus anginosus'', ''Streptococcus intermedius'', and ''Streptococcus constellatus.''〔Dalvance (dalbavancin) for injection Full Prescribing Information. http://content.stockpr.com/duratatherapeutics/files/docs/Dalvance+APPROVED+USPI.PDF 〕 Based on MIC data and other studies, dalbavancin is more potent and bactericidal and therefore requires lower concentrations than vancomycin against these organisms.〔Bennet JW, Lewis JS, Ellis MW (2008). "Dalbavancin in the treatment of complicated skin and soft-tissue infections: a review." ''Therapeutics and Clinical Risk Management'' 4 (1): 31-40. (PMC 2503664 ).〕 Dalbavancin also shows ''in vitro'' activity against vancomycin-susceptible ''Enterococcus faecium'' and ''Enterococcus faecalis''.〔 Other Gram-positive organisms belonging to the ''Bacillus'' spp., ''Listeria'' spp., and ''Corynebacterium'' spp. may show ''in vitro'' susceptibility, and dalbavancin may exhibit activity against enterococci expressing the VanB or VanC phenotype of acquired resistance against vancomycin.〔〔FDA Briefing Document: Anti-Infective Drugs Advisory Committee Meeting. NDA 21-883: Dalvance (Dalbavancin) for Injection. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM390792.pdf〕 There is no clinically significant activity against Gram-negative bacteria.〔 Two trials, DISCOVER 1 and DISCOVER 2, demonstrated noninferiority of dalbavancin compared to vancomycin/linezolid in the treatment of ABSSSI. Patients were randomly assigned to receive two doses of dalbavancin on days 1 and 8, or to receive intravenous vancomyin for at least 3 days with the option of switching to oral linezolid to complete 10 to 14 days of therapy. Investigators assessed the cessation of spread of infection-related erythema and the absence of fever at 48 to 72 hours as the primary endpoint and found that once-weekly dalbavancin was as effective as twice-daily intravenous vancomycin followed by oral linezolid. This once-weekly dosing regimen may offer an advantageous treatment option compared to daily or twice-daily dosing.〔 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Dalbavancin」の詳細全文を読む スポンサード リンク
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