for myelofibrosis, polycythemia vera, and graft-versus-host disease
FDA approved Jakafi XR — once-daily extended-release ruxolitinib — across the three approved Jakafi indications (myelofibrosis, polycythemia vera, graft-versus-host disease). Approval lands ~2 months ahead of PDUFA and extends Incyte's franchise as the IR formulation approaches loss of exclusivity.
Myelofibrosis is a rare bone marrow disorder that disrupts blood cell production, often causing anemia, fatigue, and an enlarged spleen. Jakafi XR is an extended-release version of ruxolitinib, a drug that blocks overactive JAK1 and JAK2 signaling proteins driving the disease. By tamping down this signaling, the once-daily pill may help control symptoms and reduce spleen size in myelofibrosis patients.
This was a randomized, double-blind, placebo-controlled, 29-day, multicenter study to assess the efficacy and safety of ruxolitinib + standard-of-care (SoC) therapy, compared with placebo + SoC therapy, in patients aged ≥12 years with COVID-19 disease.
Source: ClinicalTrials.gov