PharmaEssentia Japan, the Japanese subsidiary of
PharmaEssentia Corporation (TPEx:6446), a global biopharmaceutical innovator based in
Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in
hematology and oncology, announced that it has submitted a marketing authorization
application to the Ministry of Health, Labour and Welfare (MHLW) for ropeginterferon alfa-2b for
the treatment of adults with polycythemia vera (PV).
The application is based on a series of clinical development programs including a phase II
clinical study in Japan (A19-201 study) and a global phase III clinical study (PROUD-PV study)
and its extension study (CONTINUATION-PV study). The treatment received approval for the PV
indication by the U.S. Food and Drug Administration in 2021, and was approved by the
European Medicines Agency (EMA) in 2019 (brand name: BESREMi®
“We congratulate our Japanese colleagues on this important milestone toward bringing
ropeginterferon to the PV community in Japan,” said Meredith Manning, U.S. General Manager.
“We believe strongly in our mission to introduce this next-generation therapeutic option to
advance the care of PV, and are encouraged to see continued progress in reaching more patient communities around the world.”
More information please visit: PharmaEssentia