On March 14, 2021 PharmaEssentia Corporation (TPEx: 6446), a global biopharmaceutical innovator leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the company’s Biologics License Application (BLA) for ropeginterferon alfa-2b-njft for the treatment of polycythemia vera (PV), a rare blood cancer (Press release, PharmaEssentia, MAR 14, 2021, View Source [SID1234576612]).
The rationale for the CRL was COVID-related travel restrictions, which delayed a required pre-approval inspection of the company’s manufacturing facility in Taiwan. The FDA also indicated a need for additional data about the administration format with the product. Importantly, no concerns were raised about the clinical profile of the product.
"We are confident that we can work with the Agency to address the requests highlighted in the response letter and resubmit in an expeditious manner," said Meredith Manning, U.S. General Manager. "We remain fully committed to introducing ropeginterferon alfa-2b-njft to the U.S. PV community."
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.