Taiwan’s Ministry of Health and Welfare has approved ropeginterferon alfa-2b-njft (BESREMi) for adult patients with essential thrombocythemia, according to PharmaEssentia, the manufacturer of the drug.
The company reported that this is the first global approval of ropeginterferon alfa-2b-njft in this indication and represents the first new therapy approved for ET in nearly three decades.
This decision by Taiwan’s regulatory agency was based on the phase 3 SURPASS-ET clinical trial. The data showed ropeginterferon alfa-2b-njft achieved superior durable response rates compared to standard treatments in high-risk patients, and it has been added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for the treatment of ET, Pharma Essentia reported.
“This first global approval of BESREMi® in ET represents an important strategic milestone for PharmaEssentia and further strengthens the Company’s leadership position in myeloproliferative neoplasms,” said Ko-Chung Lin, PhD, founder and CEO of PharmaEssentia. “We believe ET represents a major long-term growth opportunity for BESREMi® and has the potential to significantly expand the reach of the Company’s hematology franchise globally. This approval also advances our broader strategy to expand the global BESREMi® franchise as we continue preparations for a potential US approval and commercial launch in ET later this year.”
The US Food and Drug Administration is currently reviewing a Supplemental Biologics License Application for the therapy, with a regulatory target action date set for late August 2026.
The treatment holds Orphan Drug status in the US for the treatment of polycythemia vera in adult patients. Ropeginterferon alfa-2b-njft has received regulatory approval in over 40 countries, including from the European Medicines Agency (2019), the FDA (2021), and the Pharmaceuticals and Medical Devices Agency in Japan (2023).
Leave feedback about this