PharmaEssentia Announces Taiwan Approval of BESREMi® for Essential Thrombocythemia, Marking First Global Approval in ET
First global approval of BESREMi® in essential thrombocythemia supports continued expansion of the PharmaEssentia MPN franchise; U.S. PDUFA date remains on track for August 30, 2026
BESREMi® becomes first new approved therapy for ET in nearly 30 years
PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced that the Taiwan's Ministry of Health and Welfare (MOHW) has approved ropeginterferon alfa-2b-njft (BESREMi®) for the treatment of adult patients with essential thrombocythemia (ET). BESREMi® is the first new therapy approved for ET in nearly 30 years.
The approval represents the first global regulatory approval of BESREMi® in ET and marks an important milestone in the strategy to expand BESREMi across myeloproliferative neoplasms (MPNs). With the first global approval in ET now secured in Taiwan, BESREMi® is well-positioned to address a significant global market opportunity, including in the United States, where the U.S. Food and Drug Administration (FDA) is currently reviewing a supplemental Biologics License Application (sBLA) for ET with a Prescription Drug User Fee Act (PDUFA) target action date of August 30, 2026.
