Burlington, Mass. — PharmaEssentia USA Corporation said Taiwan’s Ministry of Health and Welfare has approved ropeginterferon alfa-2b-njft, sold as BESREMi, for the treatment of adult patients with essential thrombocythemia.
The approval marks the first global regulatory approval of BESREMi in essential thrombocythemia, or ET, and makes it the first new therapy approved for ET in nearly 30 years, the company said.
PharmaEssentia said the approval supports its strategy to expand BESREMi across myeloproliferative neoplasms, or MPNs. The company is also seeking approval in the United States, where the U.S. Food and Drug Administration is reviewing a supplemental Biologics License Application for ET. The FDA’s target action date is August 30, 2026.
ET is a chronic myeloproliferative neoplasm marked by excessive platelet production and increased risk of thrombosis and hemorrhage. PharmaEssentia said data from the Phase 3 SURPASS-ET and Phase 2 EXCEED-ET studies support the potential use of BESREMi across a broad ET patient population.
“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, Ph.D., Founder and Chief Executive Officer of PharmaEssentia.
Lin said ET represents a major long-term growth opportunity for BESREMi and could significantly expand the company’s hematology franchise globally.
The Taiwan approval was supported by data from the global Phase 3 SURPASS-ET study, which evaluated ropeginterferon alfa-2b in high-risk ET patients who were resistant or intolerant to hydroxyurea. In the trial, BESREMi demonstrated a superior durable clinical response rate compared with anagrelide, at 42.9 percent versus 6.0 percent.
Across clinical studies, PharmaEssentia said BESREMi demonstrated clinically meaningful hematologic responses, molecular responses and a manageable safety profile.
The company said ropeginterferon alfa-2b has also been added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for the treatment of ET, supporting increased adoption of interferon-based treatment approaches in ET and other MPNs.
PharmaEssentia is the inventor and owner of BESREMi and maintains intellectual property rights for the product across all indications.
