2009.07.21 – Assessment for INCB18424

July 21, 2009 7:31 AM ET

Incyte reaches agreement with FDA on a Special Protocol Assessment for INCB18424 in myelofibrosis. Co announces that it has reached agreement with the FDA regarding a Special Protocol Assessment on the design of a pivotal Phase III trial for its lead JAK1/JAK2 Inhibitor, INCB18424, in patients with primary myelofibrosis, post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. The SPA provides agreement that the study design and planned analysis of the Phase III trial adequately address objectives in support of a regulatory submission.