PharmaEssentia USA Corporation, a subsidiary of Taiwan-based PharmaEssentia Corp., a global biopharmaceutical innovator leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced that the United States Food and Drug Administration (FDA) has accepted the Company’s resubmission of its Biologics License Application (BLA) seeking approval for ropeginterferon alfa-2b-njft for the treatment of polycythemia vera (PV), a rare blood cancer. The FDA has assigned a six-month review period for the resubmitted application and provided November 13, 2021 as the target Prescription Drug User Fee Act (PDUFA) action date.
“The FDA’s acceptance of our resubmitted application for ropeginterferon alfa-2b-njft is a positive step forward and we will work actively with the Agency during its review,” said Meredith Manning, U.S. General Manager. “We eagerly look forward to contributing to advances in care through a new therapeutic solution for this challenging rare blood cancer.”
Ropeginterferon alfa-2b-njft has Orphan Drug designation for the treatment of PV in the United States. Marketed as Besremi® in Europe, the product was approved by the European Medicines Agency (EMA) in 2019. The molecule was invented and is manufactured by PharmaEssentia.