EMA validates GSK marketing application for myelofibrosis treatment momelotinib

The European Medicines Agency (EMA) has validated a marketing authorisation application for momelotinib, a drug developed by GSK for the treatment of myelofibrosis. The submission marks a step toward potential approval for the therapy, which aims to treat common manifestations of the rare bone marrow cancer, including anemia and splenomegaly.

The regulatory filing is supported by data from the phase III MOMENTUM trial, which compared momelotinib against danazol in patients previously treated with other JAK inhibitors. The trial met its primary and secondary endpoints, showing reductions in symptom scores, blood transfusion requirements, and spleen volume.

Momelotinib utilizes a distinct mechanism of action compared to current standards, inhibiting JAK1 and JAK2 enzymes along with the ACVR1 receptor. Researchers believe targeting ACVR1 could directly address the high levels of hepcidin associated with anemia in myelofibrosis patients.

GSK expects an opinion from the EMA's Committee for Medicinal Products for Human Use (CHMP) by the end of 2023. A parallel regulatory review is ongoing in the United States, with the FDA expected to reach a decision in June 2023.