GSK said the European Medicines Agency had validated its marketing authorisation application for momelotinib, a potential new oral treatment for the blood cancer myelofibrosis after meeting key endpoints in a Phase 3 trial.
Momelotinib has a differentiated mechanism of action, with inhibitory ability which could address the “significant” medical needs of myelofibrosis patients with anaemia, the UK pharmaceutical company said on Friday.
Myelofibrosis is a rare blood cancer characterised by constitutional symptoms, an enlarged spleen and progressive anaemia. It affects around 20,000 patients in the US, with about 40% of patients already anaemic at the time of diagnosis and nearly all patients estimated to develop anaemia eventually.
Patients will often require transfusions, and more than 30% will discontinue treatment due to anaemia.
“Anaemia and transfusion dependence strongly correlate with poor prognosis and shortened survival,” GSK said.
Reporting by Frank Prenesti for Sharecast.com
