PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation, a global biopharmaceutical innovator based in Taiwan, has 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 US 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.
ET is a chronic MPN characterised by excessive platelet production and increased risk of thrombosis, hemorrhage. Based on data from the Phase 3 SURPASS-ET and Phase 2 EXCEED-ET studies, PharmaEssentia believes BESREMi® has the potential to address a broad ET patient population regardless of underlying disease subtype, supporting a significant global expansion opportunity for the BESREMi® franchise.
