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Ono Pharmaceutical has reported that the European Commission has granted Orphan Medicinal Product Designation to sapablursen (ONO-0530) for polycythemia vera (PV)
Sapablursen previously received US FDA Fast Track (Jan 2024), Orphan Drug (Aug 2024) & Breakthrough Therapy (May 2025) designations, plus Japan Orphan Drug Designation (Sep 2026)
A trial-in-progress poster on the global P-III (INTREPID) study of sapablursen in phlebotomy-dependent PV, developed by Deciphera (Ono’s US subsidiary), will be presented at ASH 2026 (Poster 3771; Dec 13)
Ref: Ono Pharmaceutical | Image: Ono Pharmaceutical | Press Release
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The post Ono’s Sapablursen Receives the EC’s Orphan Medicinal Product Designation for Polycythemia Vera appeared first on PharmaShots.