Incyte Corporation
Incyte Reaches Agreement with FDA on a Special Protocol Assessment for INCB18424 in Myelofibrosis
Published in Medical Letter on the CDC and FDA, August 9th, 2009
Incyte Corporation (Nasdaq:INCY) announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a pivotal Phase III trial for its lead JAK1/JAK2 Inhibitor, INCB18424, in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis (PET-MF). 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.
COMFORT-I (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Treatment), is a double-blind,...
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