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An Open-label, Single Arm, Phase III Study to Assess the Self-administration of AOP2014 Using a Pre-filled Pen, Developed for the Treatment of Polycythemia Vera Patients

Trial Profile

An Open-label, Single Arm, Phase III Study to Assess the Self-administration of AOP2014 Using a Pre-filled Pen, Developed for the Treatment of Polycythemia Vera Patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Ropeginterferon alfa-2b (Primary)
  • Indications Polycythaemia vera
  • Focus Registrational; Therapeutic Use
  • Acronyms PEN-PV
  • Sponsors AOP Orphan Pharmaceuticals AG
  • Most Recent Events

    • 20 Feb 2019 According to an AOP Orphan Pharmaceuticals AG media release, the European Commission (EC) has granted Marketing Authorization for BESREMi (Ropeginterferon alfa-2b) as first line monotherapy in adults for the treatment of Polycythaemia Vera (PV) without symptomatic splenomegaly. The EC approval was based on data generated in the clinical development program, comprising of pivotal PROUD-PV, PEN-PV, PEGINVERA and the ongoing trial CONTINUATION-PV.
    • 25 Jun 2017 Final results of the study presented at the 22nd Congress of the European Haematology Association.
    • 25 Jun 2017 Results published in an AOP Orphan Pharmaceuticals AG media release.
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