U.S. FDA Accepts PharmaEssentia’s BLA Resubmission for ropeginterferon alfa-2b-njft for the Treatment of Polycythemia Vera (PV)
- Category: Proteins and Peptides
- Published on Friday, 04 June 2021 14:09
- Hits: 553
FDA assigns a new PDUFA action date of November 13, 2021
BURLINGTON, MA, USA I June 3, 2021 I PharmaEssentia USA Corporation, a subsidiary of Taiwan-based PharmaEssentia Corp. (TPEx: 6446), 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.
PharmaEssentia Corporation (TPEx: 6446), based in Taipei, Taiwan, is a rapidly growing biopharmaceutical innovator. Leveraging deep expertise and proven scientific principles, the company aims to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one product already approved in Europe and a diversifying pipeline. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today the company is expanding its global presence with operations in the U.S., Japan, China and Korea, along with a world-class biologics production facility in Taichung. For more information, visit our website or find us on LinkedIn and Twitter.