AOP Orphan Pharmaceuticals GmbH (AOP Health) announced the publication of final results on the recently developed interferon therapy, ropeginterferon alfa-2b, in patients with polycythemia vera (PV) in the prestigious journal Leukemia1. The full publication expands on results presented at the Annual Meeting of the European Hematology Association. Results of long-term treatment in the CONTINUATION-PV study provide further evidence of the disease modifying capacity of ropeginterferon alfa-2b in PV.
“AOP Health has invested in a comprehensive clinical research program for ropeginterferon alfa-2b in PV, which has led to the approval by the health authorities in several countries. We are very proud that our scientific work has contributed to addressing the questions that are important to patients”, says Dr. Rudolf Widman, Founder and Board Member of the AOP Health Group.
Professor Heinz Gisslinger from the Medical University of Vienna, the first author of the paper, adds: “Ropeginterferon alfa-2b is already established as an effective first-line treatment for patients with PV. These new results suggest that its potential should be considered when evaluating treatment options.”
Ropeginterferon alfa-2b is a long-acting, mono-pegylated proline interferon (ATC L03AB15). It is administered once every 2 weeks initially, or up to monthly following stabilization of hematological parameters.
AOP Health’s pivotal clinical development program for ropeginterferon alfa-2b includes the studies PEGINVERA, PROUD-PV and CONTINUATION-PV. The latter is an open-label, multicenter, phase IIIb study assessing the long-term efficacy and safety of ropeginterferon alfa-2b versus hydroxyurea (HU) or best available treatment (BAT) in patients with high-risk or low-risk PV who previously participated in the randomized, controlled PROUD-PV study.
Clinical research conducted by AOP Health in Europe since 2010 has led to marketing authorization of BESREMi® for the treatment of PV, first granted by the European Commission in 2019, and thereafter by Switzerland, Liechtenstein, Israel, Bahrain, Taiwan, South Korea, Japan and the USA.
