- Design of Phase 3 INTREPID study of sapablursen in polycythemia vera to be presented at the 68th American Society of Hematology Annual Meeting
- Sapablursen has also received Orphan Drug Designations for polycythemia vera in the United States, Japan and Europe
OSAKA, Japan--(BUSINESS WIRE)--Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”) today announced that the European Commission has granted Orphan Medicinal Product Designation to sapablursen (ONO-0530) in polycythemia vera (PV). Sapablursen has previously received Fast Track Designation in January 2024, Orphan Drug Designation in August 2024, and Breakthrough Therapy Designation in May 2025 from the U.S. Food and Drug Administration (FDA). In Japan, sapablursen received Orphan Drug Designation in September 2026.
In addition, a trial-in-progress poster about the global Phase 3, double-blind, randomized controlled INTREPID study of sapablursen in patients with PV, which is being developed by Deciphera, Ono’s U.S. subsidiary, will be presented at the 68th American Society of Hematology Annual Meeting, being held December 12-15, 2026, in New Orleans, Louisiana.
The poster presenta...