Vibativ is a lipoglycopeptide antibiotic that is a semisynthetic derivative of vancomycin. The drug exhibits a dual bactericidal mechanism of action. It inhibits bacterial cell wall biosynthesis through binding to late-stage peptidoglycan precursors. Its hydrophobic side chain also enables it to bind to the bacterial cell membrane causing disruption in its integrity. The drug has demonstrated activity against a range of Gram-positive bacterial strains exhibiting resistance to other antibacterial agents including methicillin-resistant Staphylococcus aureus (MRSA), the VanB phenotype of vancomycin-resistant Enterococci (VRE), as well as strains resistant to Cubicin (daptomycin; Cubist Pharmaceuticals/Novartis/Merck & Co/AstraZeneca) and Zyvox (linezolid; Pfizer). It also has activity against vancomycin-intermediate Staphylococcus aureus (VISA), but not vancomycin-resistant Staphylococcus aureus (VRSA). Furthermore, Vibativ has not demonstrated cross-resistance with other classes of antibacterial agents.
Theravance developed Vibativ (telavancin) as a first-in-class lipoglycopeptide antibiotic. The drug’s first approval for the treatment of complicated skin and skin structure infections (cSSSI) was in the US market in 2009. In August 2013, Theravance re-launched the drug in this market after production issues forced a hold on its distribution in November 2011. Safety and efficacy concerns have prevented Vibativ’s approval in the EU markets. Potential toxic effects during pregnancy and increased safety risks in patients with renal impairment led to black box warnings for Vibativ. The US Food and Drug Administration (FDA) also associated Vibativ’s use in the US market with a Risk Evaluation and Mitigation Strategy (REMS) program. Datamonitor Healthcare believes that Vibativ’s safety issues, as well as Theravance’s limited commercial resources, are major detrimental factors which limit the drug’s competitiveness in the cSSSI market.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 Vibativ : Skin and skin structure infections
LIST OF FIGURES
8 Figure 1: Vibativ – SWOT analysis in cSSSI
10 Figure 2: Datamonitor Healthcare’s drug assessment summary of Vibativ in cSSSI
10 Figure 3: Datamonitor Healthcare’s drug assessment summary for Vibativ in cSSSI
LIST OF TABLES
4 Table 1: Vibativ’s drug profile in cSSSI
7 Table 2: Overview of pivotal trial data for Vibativ in cSSSI
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