“The approval of Jakafi XR reinforces Incyte’s leadership in hematology and our focus on meeting the evolving needs of patients with myeloproliferative neoplasms (MPNs) and GVHD,” said Bill Meury, Chief Executive Officer, Incyte. “Jakafi XR offers appropriate patients and physicians a once-daily option, expanding choice without changing the well-established role of Jakafi in clinical practice.”

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.¹

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.²

“Patients living with chronic conditions like MPNs and GVHD often struggle with managing complex treatment regimens or have multiple conditions,” said Naveen Pemmaraju, M.D., Professor of Leukemia, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center. “Since its initial approval in 2011, ruxolitinib has helped transform the treatment landscape for patients with MPNs and GVHD. With the approval of Jakafi XR, appropriate patients now have the choice of a single daily tablet.” Researchers at UT MD Anderson have led several clinical trials in the development of ruxolitinib.