September 15, 2023 Ojjaara (momelotinib) approved in the US as the first and only treatment indicated for myelofibrosis patients with anemia Approval is for use in myelofibrosis patients with anemia regardless of prior myelofibrosis therapy Nearly all myelofibrosis patients are estimated to develop anemia over the course of the disease, and over 30% will discontinue […]
FDA Extends Review Period for GSK’s Momelotinib
Today, GSK plc (LSE/NYSE: GSK) has announced that the US Food and Drug Administration (FDA) has extended the review period of the New Drug Application (NDA) for momelotinib by an additional three months to allow for the evaluation of newly submitted data. The revised completion date is now set for 16th September 2023. Despite this […]
Momelotinib: emerging treatment for myelofibrosis patients with anemia
Abstract The suite of marked anemia benefits that momelotinib has consistently conferred on myelofibrosis (MF) patients stem from its unique inhibitory activity on the BMP6/ACVR1/SMAD and IL-6/JAK/STAT3 pathways, resulting in decreased hepcidin (master iron regulator) expression, higher serum iron and hemoglobin levels, and restored erythropoiesis. Clinical data on momelotinib from the phase 2 and the […]
