Business
Sumitomo Pharma America Announces that the European Medicines Agency Has Granted Orphan Drug Designation to Nuvisertib (TP-3654) for the Treatment of Myelofibrosis
Sumitomo Pharma America, Inc. (SMPA) today announced that the European Medicines Agency (EMA) granted Orphan Drug Designation to nuvisertib (TP-3654), an oral investigational highly selective inhibitor of PIM1 kinase, for the treatment of patients with myelofibrosis (MF).
About this update from Sumitomo Pharma Co.ltd.
[{"type":"text","content":"– Nuvisertib (TP-3654), an oral investigational highly selective PIM-1 kinase inhibitor, is being evaluated in patients with relapsed or refractory myelofibrosis (MF) –","length":168,"tagName":"p","attribs":{}},{"type":"text","content":"MARLBOROUGH, Mass., July 30, 2025 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA) today announced that the European Medicines Agency (EMA) granted Orphan Drug Designation to nuvisertib (TP-3654), an oral investigational highly selective inhibitor of PIM1 kinase, for the treatment of patients with myelofibrosis (MF).","length":322,"tagName":"p"},{"type":"image","alt":"SMPA Logo (PRNewsfoto/Sumitomo Pharma America)","displaySize":"","headline":null,"caption":"SMPA Logo (PRNewsfoto/Sumitomo Pharma America)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":54,"url":"https://media.zenfs.com/en/prnewswire.com/36c67330cea4d215e392946ca6461778"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/s5pb1ghAEWSETpWimf6IZA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTk1O2NmPXdlYnA-/https://media.zenfs.com/en/prnewswire.com/36c67330cea4d215e392946ca6461778","width":400,"height":54}},"href":"https://mma.prnewswire.com/media/2206351/Sumitomo_Pharma_updated_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"Orphan Drug Designation is granted by the EMA to investigational therapies addressing rare diseases or conditions that affect not more than 5 in 10,000 people in the European Union, and for which there is no satisfactory method of diagnosis, prevention or treatment of the condition. This designation comes on the heels of the recent U.S. Food and Drug Administration (FDA) Fast Track Designation granted to nuvisertib, and following the oral presentation of updated preliminary Phase 1/2 data at the European Hematology Association (EHA) 2025 Congress in Milan, Italy.","length":569,"tagName":"p"},{"type":"text","content":""Following the recent FDA Fast Track Designation, being granted Orphan Drug Designation from European regulators emphasizes the potential of nuvisertib as a future option for patients living with myelofibrosis," said Tsutomu Nakagawa, Ph.D, President and Chief Executive Officer of SMPA. "As we pursue our mission of addressing unique and unmet patient needs, we look forward to working with the EMA to advance the clinical develop...