India, May 2 -- Incyte (INCY) announced that the U.S. Food and Drug Administration 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, and adults and children aged 12 years and older with steroid-refractory acute or chronic graft-versus-host disease (GVHD) after failure of one or two lines of systemic therapy.
The approval was based on a clinical study demonstrating that a single 55 mg Jakafi XR tablet taken once daily (QD) is bioequivalent to a single 25 mg Jakafi immediate-release (IR) tablet taken twice daily (BID). Jakafi XR will be availabl...