Incyte Wins FDA Approval for Once-Daily Jakafi XR for Blood Disorders

Rare Daily Staff

The U.S. Food and Drug Administration approved Incyte’s Jakafi XR, a once-daily extended-release version of ruxolitinib, for adults with intermediate- or high-risk myelofibrosis, adults with polycythemia vera who cannot adequately use hydroxyurea, and adults and children 12 and older with certain forms of graft-versus-host disease.

Myelofibrosis is a rare chronic blood cancer in which abnormal bone marrow function leads to scar tissue, worsening anemia, fatigue and an enlarged spleen or liver. Polycythemia vera is another rare blood cancer in which the bone marrow makes too many blood cells, thickening the blood and raising the risk of clots, stroke or heart attack. Graft-versus-host disease is a serious complication of stem cell transplant in which donor cells attack the recipient’s organs, often affecting the skin, digestive tract and liver.

Jakafi XR is a JAK1/JAK2 inhibitor designed to block overactive signaling pathways involved in abnormal blood-cell production and immune activity. Incyte said the new tablet contains the same active ingredient as Jakafi but in a once-daily formulation, and the FDA approval was based on a study showing that one 55-mg Jakafi XR tablet taken daily was bioequivalent to one 25-mg Jakafi tablet taken twice daily.

The company said Jakafi XR will be available for pharmacy orders by May 8. Incyte CEO Bill Meury said the approval gives patients and physicians a once-daily option without changing Jakafi’s established role in clinical practice.

Incyte said the safety profile was established from prior Jakafi studies and includes low blood counts, infections and other risks, with the most common side effects varying by disease.