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Mocravimod granted Orphan Drug Designation by the FDA
On November 27, 2023, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to mocravimod (also known as KRP203), a novel synthetic sphingosine-1-phosphate receptor modulator, to improve outcome after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with hematologic malignancies.1
Mocravimod was previously granted Orphan Drug Designation by the U.S. FDA and the European Medicines Agency (EMA) for the treatment of patients with acute myeloid leukemia undergoing allo-HSCT.2 The safety and efficacy of mocravimod, both as an adjunctive and maintenance therapy, for patients with acute myeloid leukemia receiving allo-HSCT is currently being investigated in the phase III MO-TRANS trial (NCT05429632), which will enroll around 250 adult patients.1
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