PharmaEssentia Japan submits an NDA in Japan for the polycythemia vera (PV) treatment ropeginterferon alfa-2b.
PharmaEssentia Japan has submitted a new drug application (NDA) in Japan for the polycythemia vera (PV) treatment ropeginterferon alfa-2b (development code: P1101).
This is the Taiwan-based biopharma's first NDA filed in Japan. Ropeginterferon alfa-2b is a novel, mono-pegylated, long-acting proline interferon. Its pharmacokinetic properties have been improved to give it a longer dosing interval than conventional pegylated interferon. PV is a rare hematological disease originating from the overproduction of red blood cells due to an abnormality of hematopoietic stem cells in bone marrow. It is a type of myeloproliferative tumor. The application is based on the results of clinical development programs including a PII trial (A19-201 study) in Japan. The product was approved by the US FDA in 2021, and by the European Medicines Agency (EMA) in 2019.
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