AOP Orphan´s submission for marketing authorization of Ropeginterferon alfa-2b for treatment of Polycythemia Vera (PV) in the European Union (EU) has resumed after clock-stop. The conclusion of this centralized procedure is expected for Q4/2018.
Interferons (IFNs) have been successfully applied in various hematological malignancies including PV, Chronic Myeloid Leukemia (CML) and other myeloproliferative neoplasms (MPNs) for about three decades, however no IFN has obtained regulatory approval in these indications yet.
Ropeginterferon alfa-2b is the first monopegylated IFN with an improved application of only once every two weeks (and only once per month in long-term maintenance treatment). The innovative pegylation technology and the molecule have been invented by PharmaEssentia Corporation (Taiwan Stock Exchange: 6446), a long-term partner of AOP Orphan.
In 2009, AOP Orphan has in-licensed from PharmaEssentia Corporation the exclusive rights to develop and commercialize Ropeginterferon alfa-2b in PV, CML and other MPNs for European, Commonwealth of Independent States (CIS), and Middle Eastern markets.
Since 2009, AOP Orphan´s Development Program in PV including the phase I/II trial PEGINVERA and the phase III trials PROUD-PV, PEN-PV and CONTINUATION-PV, have established high efficacy and favorable safety and tolerability of Ropeginterferon alfa-2b in PV. PharmaEssentia Corporation has invested in preparations for commercialization of the drug in its territory and in the capability for commercial manufacturing of the drug. The company´s world-class cGMP biologics facility in Taichung is certified by the Taiwan Food and Drug Administration (TFDA) and since 2018 also by EMA , and it is designed and operated to be compliant with all U.S. FDA requirements.
Commercial availability of Ropeginterferon alfa-2b is expected to fulfill an increasing need of patients and physicians for the long-term management of a yet incurable class of diseases.