GSK’s Ojjaara approved by FDA for patients with myelofibrosis and anaemia

Betsy Goodfellow | September 18, 2023 | News story | Medical Communications FDA, GSK, Haematology, Ojjaara, anaemia, myelofibrosis 

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 subpopulation 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.

Nina Mojas, senior vice president of Oncology Global Product Strategy at GSK, commented: “The vast majority of myelofibrosis patients eventually develop anaemia, causing them to discontinue treatments and require transfusions. Given this high unmet need, we are proud to add Ojjaara to our oncology portfolio and address a significant medical need in the community. We look forward to helping improve outcomes in this difficult-to-treat blood cancer.”

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.”

Betsy Goodfellow

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