GSK's momelotinib submission accepted for review by Japanese regulator

Japan’s Ministry of Health, Labor and Welfare (MHLW) has accepted for review a new drug application (NDA) for momelotinib, filed by UK pharma major GSK (LSE: GSK).

Momelotinib is a potential new medicine with a differentiated mechanism of action that may address the significant medical needs of myelofibrosis patients, especially those with anemia. The NDA is based on data from the pivotal phase III trials SIMPLIFY-1 and MOMENTUM.

Myelofibrosis is a blood cancer that can lead to splenomegaly (enlarged spleen); constitutional symptoms such as fatigue, night sweats, and bone pain; and severely low blood counts, including anemia and thrombocytopenia. About 70% of patients diagnosed with primary myelofibrosis and about half of patients diagnosed with secondary myelofibrosis in Japan have moderate to severe anemia at the time of diagnosis, and nearly all patients are estimated to develop anemia over the course of the disease. Patients who are transfusion dependent have a poor prognosis and shortened survival.