Review Extended on GSK’s Momelotinib

FDA has extended by three months its review of a GSK NDA for momelotinib, indicated for treating myelofibrosis patients with anemia, to allow more time to review recently submitted data. The revised user fee review action target date is 9/16.

GSK says momelotinib has a novel mechanism of action, with inhibitory ability along three key signaling pathways: Janus kinase (JAK) 1, JAK2, and activin A receptor, Type I (ACVR1). “Inhibition of JAK1 and JAK2 may improve constitutional symptoms and splenomegaly, it says. “Additionally, direct inhibition of ACVR1 leads to a decrease in circulating hepcidin, which is elevated in myelofibrosis and contributes to anemia.”

Myelofibrosis is a rare blood cancer that affects about 20,000 patients in the US, with about 40% of patients with anemia at the time of diagnosis, according to the company. Patients often require transfusions, and more than 30% will discontinue treatment due to anemia.