FDA accepted the NDA of GSK's momelotinib for myelofibrosis
GSK announced that the U.S. Food and Drug Administration accepted the new drug application (NDA) of momelotinib for treating patients with myelofibrosis. GSK has submitted a Phase 3 MOMENTUM trial, in which momelotinib met all the primary and secondary endpoints.
In the MOMENTUM trial, 200 mg of momelotinib was evaluated versus 600 mg danazol daily (2:1). Patients who were previously treated with JAK inhibitors and are symptomatic and anemic were included in the study. The primary endpoint was the Total Symptom Score (TSS) response rate at Week 24.
Momelotinib acts by inhibiting Janus kinase (JAK) 1 and JAK2 and activin A receptor, type I (ACVR1). Inhibiting the JAK receptor improves symptoms and splenomegaly, whereas inhibiting ACVR1 helps in reducing anemia.