FDA approves GSK’s Ojjaara for the treatment of patients with myelofibrosis and anaemia
GSK has announced that the US Food and Drug Administration (FDA) has approved Ojjaara (momelotinib) for the treatment of intermediate or high-risk myelofibrosis in adults with anaemia.
Ojjaara is a once-daily oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor and is currently the only approved medicine for both newly diagnosed and previously treated myelofibrosis patients with anaemia that treats the key manifestations of the disease, including anaemia, constitutional symptoms and splenomegaly (enlarged spleen).
The FDA’s approval of the drug follows data from the MOMENTUM trial and a sub-population of patients with anaemia in the SIMPLIFY-1 phase 3 trial. The MOMENTUM trial assessed the drug’s safety and efficacy, meeting all of its primary and key secondary endpoints and demonstrating statistically significant response. The most common adverse reactions in both trials were thrombocytopaenia, haemorrhage, bacterial infection, fatigue, dizziness, diarrhoea and nausea.
Kapila Viges, CEO of Myeloproliferative Neoplasms (MPN) Research Foundation, added: “We are thrilled to see momelotinib reach the clinic, giving patients and their physicians another option to help manage myelofibrosis. Any new treatment that takes steps toward unlocking the mysteries of this complex and chronic blood cancer represents great progress for the field.”
Ruben A Mesa MD FACP, president and executive director of Atrium Health Levine Cancer Center and Atrium Health Wake Forest Baptist Comprehensive Cancer Center, US, stated: “With momelotinib we have the potential to establish a new standard of care for myelofibrosis patients with anaemia. Addressing key manifestations of myelofibrosis, including anaemia, constitutional symptoms and splenomegaly, makes a significant difference in the treatment regimen for these patients who have limited options to address these aspects of the disease.”