Taipei:Taiwan-based PharmaEssentia Corp. is working to broaden the availability of its blood cancer medication Ropeginterferon alfa-2b, known as Ropeg, across Europe, where it has not yet gained regulatory approval for treating essential thrombocythemia (ET). The drug has already been approved in markets such as Taiwan, Japan, the United States, and China.
According to Focus Taiwan, Ropeg has received approval to treat polycythemia vera (PV) in about 50 countries, including within the European Union, where it was approved in 2019. However, the company highlights a discrepancy between clinical advancements and patient access in Europe for ET treatment.
Both essential thrombocythemia and polycythemia vera are chronic blood cancers, categorized as myeloproliferative neoplasms (MPNs), which involve the overproduction of blood cells. Under a 2009 licensing agreement, Austria-based AOP Health is responsible for the clinical development, regulatory submissions, and commercialization of Ropeg for PV, ET, and primary myelofibrosis in Europe, the Commonwealth of Independent States (CIS), and the Middle East.
PharmaEssentia retains ownership of Ropeg's core technology and intellectual property and is responsible for its global manufacturing. The company continues to provide necessary manufacturing and quality documentation to support AOP Health's regulatory requirements and ensure a stable drug supply. Since 2018, PharmaEssentia's facility in Taichung has maintained EU Good Manufacturing Practice (GMP) certification, supplying markets worldwide as part of its goal to enhance patient access to Ropeg.
