Baku:Taipei Taiwan-based PharmaEssentia Corp. is working to expand patient access to its blood cancer drug, Ropeg, in Europe, where it has yet to gain regulatory approval for essential thrombocythemia (ET), despite having approvals in several other major markets.
According to Focus Taiwan, Ropeginterferon alfa-2b (Ropeg), developed and produced by PharmaEssentia, has been approved for treating ET in Taiwan, Japan, the United States, and China. However, the drug still lacks approval in Europe for treating ET, reflecting a disparity in patient access and clinical advancements across different markets.
Ropeg has been approved for treating polycythemia vera (PV) in about 50 countries globally, including the European Union, where it received regulatory approval in 2019. Both ET and PV are chronic blood cancers classified as myeloproliferative neoplasms (MPNs), which involve the excessive production of blood cells.
Under a 2009 licensing agreement, Austria-based AOP Health is tasked with 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 manufacturing the drug for global supply.
PharmaEssentia continues to provide manufacturing and quality documentation to AOP Health to support their regulatory obligations, while also supplying the drug under the agreement's terms. The company's Taichung facility has maintained EU Good Manufacturing Practice (GMP) certification since 2018, ensuring a stable global drug supply, and PharmaEssentia aims to improve patient access worldwide.
