Dalvance is a second-generation, semi-synthetic lipoglycopeptide antibacterial compound of the same class as vancomycin. The drug inhibits the formation of, and disrupts the integrity of, the bacterial cell wall. Dalvance is a once-weekly intravenous bactericidal agent that targets a broad range of clinically significant Gram-positive bacteria including Staphylococcus aureus and certain Streptococcal and Enterococcal strains. The drug has shown efficacy against the clinically significant MRSA. Dalvance has also demonstrated activity against vancomycin-intermediate Staphylococcus aureus (VISA), but has poor activity against vancomycin-resistant Staphylococcus aureus (VRSA). Dalvance’s lipophilic side chain enhances its antibacterial efficacy by increasing its affinity and binding to the bacterial cell wall. In vitro studies indicated that Dalvance’s potency against several Gram-positive bacterial strains is four to 32 times greater than that of vancomycin, Cubicin (daptomycin; Cubist Pharmaceuticals/Novartis/Merck & Co/AstraZeneca), and Zyvox (linezolid, Pfizer).
Dalvance (dalbavancin; Durata Therapeutics/RaQualia Pharma) is a second-generation lipoglycopeptide available as a once-a-week regimen for the treatment of acute bacterial skin and skin structure infections (ABSSSI) including cases associated with the clinically significant pathogen methicillin-resistant Staphylococcus aureus (MRSA). The drug has demonstrated non-inferior efficacy to vancomycin and Zyvox (linezolid; Pfizer) in Phase III development for ABSSSI. In the skin infections market, Dalvance is set to compete directly with Theravance’s first-to-market lipoglycopeptide Vibativ (telavancin; Theravance). Datamonitor Healthcare regards Dalvance’s flexible dosing schedule as a major advantage for the drug over Vibativ as well as other drugs targeting MRSA. A potential one-dose regimen of Dalvance will also mitigate potential threats from the other second-generation lipoglycopeptide approved for the treatment of ABSSSI, Orbactiv (oritavancin; The Medicines Company).
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Dalvance : Skin and skin structure infections
LIST OF FIGURES
10 Figure 1: Design of Dalvance’s Phase IIIb trial as a single 1,500mg dose regimen
11 Figure 2: Dalvance’s SWOT analysis in cSSSI
12 Figure 3: Datamonitor Healthcare’s drug assessment summary of Dalvance in cSSSI
13 Figure 4: Datamonitor Healthcare’s drug assessment summary for Dalvance in cSSSI
LIST OF TABLES
4 Table 1: Dalvance’s drug profile in ABSSSI
6 Table 2: Overview of pivotal trial data for Dalvance in ABSSSI
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