Meropenem/vaborbactam

Drug Profile

Meropenem/vaborbactam

Alternative Names: Carbavance; Meropenem/RPX-7009; RPX-2014/RPX-7009; RPX-7009/RPX-2014

Latest Information Update: 15 Mar 2017

Price : $50

At a glance

  • Originator Rempex Pharmaceuticals
  • Developer The Medicines Company; US Department of Health and Human Services
  • Class Antibacterials; Pyrrolidines; Small molecules; Thienamycins
  • Mechanism of Action Beta lactamase inhibitors; Cell wall inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    Urinary tract infections
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Urinary tract infections
  • Phase III Bacteraemia; Gram-negative infections; Pneumonia; Pyelonephritis

Most Recent Events

  • 21 Feb 2017 Preregistration for Urinary tract infections (Treatment-resistant, Treatment-experienced) in USA (IV)
  • 21 Feb 2017 US FDA accepts NDA for meropenem/vaborbactam for Urinary tract infections (Treatment-resistant, Treatment-experienced) for priority review
  • 15 Dec 2016 The Medicines Company plans the phase III TANGO 3 trial for Pneumonia in the US and the EU (NCT03006679)
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