Ema accepts the application for marketing authorization for momelotinib

The European Medicines Agency (EMA) has accepted the application for approval of momilutinib, a potential new oral treatment for myelofibrosis (fibrosis of the bone marrow). The app includes data from major Phase III studies, including the pivotal MOMENTUM study, which met all major primary and secondary endpoints of efficacy.

02 Dec The European Medicines Agency (EMA) has accepted an application for approval of momilutinib, a potential new oral treatment for myelofibrosis (fibrosis of the bone marrow). Momilutinib has a divergent mode of action, with inhibitory ability along three major signaling pathways: Janus kinase (JAK) 1 and JAK2, and activin A receptor type I (ACVR1), which may address the needs of patients with myelofibrosis (fibrosis of the bone marrow) with anemia. the blood.

The authorization is based on results from major phase III studies, including the pivotal MOMENTUM study, which achieved all major primary and secondary endpoints, including total symptom score (TSS), transfusion independence rate (TI) and splenic response rate (SRR). Data from the primary analysis from the MOMENTUM phase III study were presented at the recent meeting of the American Society of Clinical Oncology and the European Society of Hematology conference. The updated 48-week data will be presented at the upcoming meeting of the American Society of Hematology (ASH) scheduled for December 10-13. Action from the Committee for Medicinal Products for Human Use (CHMP) is expected by the end of 2023, and the application for momilutinib is currently under review by the US Food and Drug Administration (FDA). Momelotinib is not currently approved in any market. Once approved by the regulatory authorities, it will be the only drug for the main manifestations of myelofibrosis (fibrosis of the bone marrow), including anemia and an enlarged spleen.

December 02, 2022
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