Sierra Oncology announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to momelotinib, a JAK1, JAK2, and ACVR1 inhibitor, for the treatment of patients with intermediate/high-risk myelofibrosis.
“Fast Track designation for momelotinib highlights the serious and significant unmet needs of patients with myelofibrosis who have previously received a JAK inhibitor. These patients typically suffer from uncontrolled constitutional symptoms, progressively worsening anemia often resulting in transfusion dependence, and enlarged spleens. Fast Track also recognizes the absence of FDA-approved treatments for these patients and that momelotinib has the potential to address their unmet needs,” said Dr. Barbara Klencke, Chief Development Officer of Sierra Oncology. “We look forward to continuing to work closely with the FDA as we launch and conduct the MOMENTUM Phase 3 trial of momelotinib, with the goal of bringing this important therapy to patients expeditiously.”
According to the FDA, “Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.” Click here to learn more about Fast Track.