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Incyte (Nasdaq: INCY) announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi XR (ruxolitinib) extended-release tablets for 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, and 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.
Jakafi XR is approved for:
FDA approval was based on a clinical study showing that a single 55 mg Jakafi XR tablet taken once daily (QD) is bioequivalent to a single 25 mg Jakafi tablet of the immediate-release (IR) dosage form taken twice daily (BID). The study reported comparable steady-state drug exposure measures, indicating the potential for similar clinical benefit.
The safety of Jakafi XR was established from adequate and well-controlled studies of Jakafi in adult patients with myelofibrosis and polycythemia vera, and in adult and pediatric patients with acute and chronic graft-versus-host disease. The most common adverse reactions reported include:
Bill Meury, Chief Executive Officer of Incyte, said the approval reinforces the company’s focus on meeting evolving patient needs in myeloproliferative neoplasms (MPNs) and GVHD, adding that Jakafi XR provides appropriate patients and physicians a once-daily option while maintaining the established role of Jakafi in clinical practice.
Naveen Pemmaraju, M.D., Professor of Leukemia at The University of Texas MD Anderson Cancer Center, said patients with MPNs and GVHD often face challenges managing complex treatment regimens, and that the approval of Jakafi XR gives appropriate patients the choice of a single daily tablet. He noted that UT MD Anderson has led multiple clinical trials in the development of ruxolitinib.
Incyte said eligible patients in the U.S. prescribed Jakafi XR have access to IncyteCARES, a program offering personalized patient support, including financial assistance, ongoing education, and additional resources.
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