PharmaEssentia has received approval from Taiwan’s Ministry of Health and Welfare (MOHW) for BESREMi® (ropeginterferon alfa-2b-njft) to treat adult patients with essential thrombocythaemia (ET). The approval marks the first global regulatory approval of BESREMi for ET and represents the first new treatment approved for the condition in nearly 30 years.

The milestone supports PharmaEssentia’s strategy to expand the use of BESREMi across myeloproliferative neoplasms (MPNs). The approval also strengthens the product’s commercial prospects in international markets, including the United States, where the U.S. Food and Drug Administration is currently reviewing a supplemental Biologics License Application for the treatment of ET. A regulatory decision is expected by 30 August 2026.

Essential thrombocythaemia is a chronic myeloproliferative neoplasm characterised by excessive platelet production and an increased risk of blood clots and bleeding complications. PharmaEssentia believes BESREMi has the potential to benefit a broad range of ET patients, regardless of disease subtype, based on results from the Phase 3 SURPASS-ET and Phase 2 EXCEED-ET clinical studies.

The Taiwan approval was supported by findings from the global Phase 3 SURPASS-ET trial, which evaluated BESREMi in high-risk ET patients who were resistant or intolerant to hydroxyurea. In the study, BESREMi demonstrated a superior durable clinical response rate compared with anagrelide, achieving response rates of 42.9% versus 6.0%.

Clinical studies also showed that BESREMi produced meaningful haematologic and molecular responses while maintaining a manageable safety profile. The data suggest the treatment may offer disease-modifying potential for patients with ET.

In addition to the ongoing FDA review, ropeginterferon alfa-2b has been included in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for the treatment of ET. The inclusion reflects growing recognition of interferon-based therapies in ET and other myeloproliferative neoplasms.

PharmaEssentia is the developer and owner of BESREMi and retains intellectual property rights for the product across all approved and investigational indications.

 

Source: pharmaessentia.com

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