BRIEF—PharmaEssentia resubmits BLA for ropeginterferon alfa-2b-njft

The US subsidiary of Taiwan-based PharmaEssentia has resubmitted its Biologics License Application (BLA) to the US 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, US general Manager.

Ropeginterferon alfa-2b-njft has Orphan Drug designation for the treatment of PV in the USA. 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.