Conestat alfa - Pharming Group NV

Drug Profile

Conestat alfa - Pharming Group NV

Alternative Names: Human C1 esterase inhibitor - Pharming; Recombinant human C1 esterase inhibitor - Pharming; rhC1INH; Rhucin; Ruconest

Latest Information Update: 18 Jan 2018

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At a glance

  • Originator Pharming Group NV
  • Class Complement C1 inactivator proteins; Recombinant proteins; Vascular disorder therapies
  • Mechanism of Action Complement C1r inhibitors; Complement C1s inhibitors
  • Orphan Drug Status

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

    Yes - Hereditary angioedema; Capillary leak syndrome; Delayed graft function
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Hereditary angioedema
  • Phase II Acute kidney injury
  • Preclinical Delayed graft function; Reperfusion injury
  • Discontinued Renal transplant rejection

Most Recent Events

  • 17 Jan 2018 The FDA has set an action date of 21/09/2018 for contesta alfa's sBLA for Hereditary angioedema (Prevention, In adolescents, In adults)
  • 17 Jan 2018 The US FDA accepts sBLA for conestat alfa for Hereditary angioedema (In adolescents, Prevention, In adults) for review
  • 08 Jan 2018 Pharming completes a phase II trial in Hereditary angioedema (In adolescents, In children) in Czech Republic, Germany, Israel, Italy, Macedonia, Poland, Romania and Slovakia (NCT01359969)
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