PharmaEssentia’s sBLA in essential thrombocythemia accepted by FDA
Taiwan-based PharmaEssentia Corporation (TWSE: 6446), a biopharma seeking to deliver new biologics in hematology and oncology, has announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for ropeginterferon alfa-2b-njft for the treatment of adult patients with essential thrombocythemia (ET).
The review classification for the application is standard, and the user fee target date for a FDA decision is August 30 of this year.
Ropeginterferon alfa-2b-njft is currently FDA-approved and marketed as Besremi for the treatment of adults with polycythemia vera (PV).
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