Sierra Oncology Inc (NASDAQ:SRRA) announced promising news Wednesday that the US Food and Drug Administration has granted fast track designation to momelotinib, used for patients with intermediate/high-risk myelofibrosis, a bone marrow cancer that disrupts the body's normal production of blood cells.
The drug development company said the fast track designation is for momelotinib, a JAK1, JAK2 and ACVR1 inhibitor, which is used for the treatment of patients with intermediate/high-risk myelofibrosis, or bone marrow cancer, who have previously received a JAK inhibitor.
"Fast Track designation for momelotinib highlights the serious and significant unmet needs of patients with myelofibrosis who have previously received a JAK inhibitor," said Dr Barbara Klencke, Sierra's Chief Development Officer. "These patients typically suffer from uncontrolled constitutional symptoms, progressively worsening anemia often resulting in transfusion dependency, and enlarged spleens."
Fast track can lead to earlier drug approval
Fast track designation is good news for the firm, and can often lead to earlier drug approval and access by patients.
"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 Klencke. "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."
Shares of the Vancouver-based company slipped Wednesday, down 6% at US$0.80 in New York.
Contact Katie Lewis at katie@proactiveinvestors.com