PharmaEssentia Corporation has received approval from Taiwan’s Ministry of Health and Welfare for Besremi (ropeginterferon alfa-2b) for the treatment of adult patients with essential thrombocythemia (ET).
- Clinical Data: Approval was supported by results from the Phase 3 SURPASS-ET study, which showed a 42.9% durable clinical response rate for Besremi compared with 6.0% for anagrelide.
- Patient Population: The treatment is indicated for adult patients with high-risk ET who are resistant or intolerant to hydroxyurea.
- Regulatory Status: A supplemental Biologics License Application (sBLA) for ET is currently under review by the US Food and Drug Administration.
This summary is based on a press release issued by PharmaEssentia Corporation via BioSpectrum Asia.
Image for illustrative purposes only. Source: Canva.
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