BURLINGTON, Mass. – 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 the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA), seeking approval for ropeginterferon alfa-2b-njft for the treatment of polycythemia vera (PV), a rare blood cancer.
The resubmission follows receipt of a complete response letter in March, in which the FDA sought additional information about the administration format with the product. Importantly, no concerns were raised about the clinical profile of the product. Also noted were COVID-related restrictions that delayed the required pre-approval inspection of the company’s manufacturing facility in Taiwan.
“We are confident that we have thoroughly addressed the information requests and look forward to engaging with the Agency throughout its review of our application, which we believe supports a positive profile for ropeginterferon alfa-2b-njft,” said Meredith Manning, U.S. General Manager. “We remain steadfast in our goal to introduce a much-needed new therapeutic option for the U.S. PV community, fostering more modern approaches to care that can help reduce the risk of disease progression.”
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.
Kellie Hotz, [email protected]