PharmaEssentia Updates Progress of Ropeginterferon Alfa-2b Clinical Program

  • 36 month analysis of ropeginterferon alfa-2b (Ropeg) phase III clinical data in Polycythemia Vera (PV) demonstrates superiority across three key aspects of disease control, including complete hematological response (CHR), disease burden, and molecular response
  • A long-term development partner of Ropeg, AOP Orphan’s submission for marketing authorization of ropeginterferon alfa-2b in the EU is in the final stage of European Medicines Agency (EMA) regulatory review
  • PharmaEssentia is continuing to discuss with the US Food and Drug Administration (FDA) the best path forward to make ropeginterferon alfa-2b available to PV patients in the US
  • PharmaEssentia is planning to initiate a global clinical development program of ropeginterferon alfa-2b in Essential Thrombocythemia (ET)

Ropeginterferon alfa-2b maintains efficacy and safety profile in PV

Ropeginterferon alfa-2b is a novel, single isomer long-acting pegylated interferon in clinical development for treatment of patients with PV. At the 2018 American Society of Hematology (ASH) Annual Meeting, Prof. Heinz Gisslinger from the Medical University of Vienna, Austria presented the 36 month update of ropeginterferon alfa-2b in patients with PV (http://www.bloodjournal.org/content/132/Suppl_1/579).

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