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A Randomized, Open-label, Multicenter, Controlled, Parallel Arm, Phase III Study Assessing the Efficacy and Safety of AOP2014 vs. Hydroxyurea in Patients With Polycythemia Vera

Trial Profile

A Randomized, Open-label, Multicenter, Controlled, Parallel Arm, Phase III Study Assessing the Efficacy and Safety of AOP2014 vs. Hydroxyurea in Patients With Polycythemia Vera

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Jun 2019

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At a glance

  • Drugs Ropeginterferon alfa-2b (Primary) ; Hydroxycarbamide
  • Indications Polycythaemia vera
  • Focus Registrational; Therapeutic Use
  • Acronyms PROUD; PROUD-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.
    • 17 Dec 2018 According to a PharmaEssentia Corporation media release, based on the comprehensive data package from the PROUD-PV/CONTINUATION-PV clinical development program, which was sponsored by AOP Orphan, the CHMP adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Besremi, intended for the treatment of polycythaemia vera without symptomatic splenomegaly.The applicant for Besremi is AOP Orphan Pharmaceuticals AG (AOP Orphan).
    • 05 Dec 2018 Results presented in the PharmaEssentia Corporation media release.
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