FDA Approves Incyte's Jakafi XR for Myelofibrosis, Polycythemia Vera, and Graft-Versus-Host Disease
The U.S. Food and Drug Administration (FDA) has approved Jakafi XR, an extended-release formulation of ruxolitinib, for the treatment of several conditions including intermediate- or high-risk myelofibrosis (MF), polycythemia vera (PV) in adults intolerant to hydroxyurea, and both acute and chronic graft-versus-host disease (GVHD) in patients aged 12 and older. Jakafi XR is a once-daily tablet that provides consistent drug exposure comparable to the twice-daily immediate-release version. This approval is based on clinical studies demonstrating bioequivalence between the two formulations. The drug is expected to be available for pharmacy orders by May 8. Incyte, the company behind Jakafi XR, emphasizes its commitment to providing treatment options that meet the evolving needs of patients with myeloproliferative neoplasms and GVHD. 
