Incyte announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi XR (ruxolitinib) extended-release tablets for the treatment of adults with intermediate- or high-risk myelofibrosis (MF); adults with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea; as well as adults and children aged 12 years and older with steroid-refractory acute graft-versus-host disease (GVHD) or chronic GVHD after failure of one or two lines of systemic therapy. FDA approval was based on a clinical study which demonstrated that a single 55 mg Jakafi XR tablet taken once-daily (QD) is bioequivalent to a single 25 mg Jakafi tablet, the immediate-release (IR) dosage form, taken twice-daily (BID). This means that, based on key measures of steady-state drug exposure, it delivers the same active ingredient at comparable levels throughout the day, indicating the potential for similar clinical benefit.
The safety of Jakafi XR has been established from adequate and well-controlled studies of Jakafi in adult patients with myelofibrosis, polycythemia vera, and adult and pediatric patients with acute and chronic graft-versus-host-disease. The most common adverse reactions associated with Jakafi in these studies include: For certain patients with MF and PV: low platelet or red blood cell counts, bruising, dizziness, headache and diarrhea; For patients with acute GVHD: low platelet counts, low red or white blood cell counts, infections and swelling; And for patients with chronic GVHD: low red blood cell or platelet counts and infections, including viral infections. Incyte is committed to supporting patients and removing barriers to access medicines.
Eligible patients in the U.S. who are prescribed Jakafi XR have access to IncyteCARES (Connecting to Access, Reimbursement, Education and Support), a comprehensive program offering personalized patient support, including financial assistance and ongoing education and additional resources.
