Ropeginterferon alfa-2b

Drug Profile

Ropeginterferon alfa-2b

Alternative Names: AOP-2014; P-1101; Peg-IFN-alpha-2b; PEG-P-IFN-alpha-2b; Pegylated proline interferon-alfa-2b

Latest Information Update: 30 Dec 2016

Price : $50

At a glance

  • Originator PharmaEssentia Corporation
  • Developer AOP Orphan Pharmaceuticals AG; Mayo Clinic; National Cancer Institute (USA); PharmaEssentia Corporation
  • Class Antineoplastics; Antivirals; Interferons; Polyethylene glycols; Small molecules
  • Mechanism of Action Interferon alpha 2b stimulants
  • Orphan Drug Status

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

    Yes - Polycythaemia vera
  • 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.

  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Essential thrombocythaemia; Hepatitis B; Polycythaemia vera
  • Phase II Chronic myeloid leukaemia; Hepatitis C; Myelofibrosis
  • Preclinical Cancer

Most Recent Events

  • 21 Dec 2016 Fondazione per la Ricerca Ospedale Maggiore and AOP Orphan Pharmaceuticals plan a phase II trial for Polycythaemia vera (Adjunctive treatment) in Italy (SC) (NCT03003325)
  • 05 Dec 2016 AOP Orphan and PharmaEssentia announce intention to submit MAA and NDA to European marketing authorization and US FDA
  • 05 Dec 2016 Final efficacy and adverse events data from the PROUD-PV phase III trial in Polycythaemia presented at the 58th Annual Meeting and Exposition of the American Society of Haematology (ASH-Hem-2016)
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