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 bone marrow cancer that disrupts normal blood cell production and often causes an enlarged spleen and severe fatigue. Jakafi XR is a once-daily, extended-release pill that calms an overactive immune and inflammatory signaling pathway by inhibiting the JAK1 and JAK2 proteins. This sustained inhibition could help manage the debilitating symptoms of the disease with a more convenient dosing schedule.
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