GSK has announced that the US Food and Drug Administration (FDA) has approved its Ojjaara (momelotinib) in the US for the treatment of myelofibrosis patients with anaemia.
Ojjaara is a once-a-day, oral inhibitor with inhibitory ability for JAK1/JAK2 and activin A receptor type 1 (ACVR1) signalling pathways.
FDA has approved the inhibitor to treat intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis in anaemia patients.
The approval was based on the findings from the MOMENTUM study and a subpopulation of anaemia patients from the SIMPLIFY-1 Phase 3 trial.
The MOMENTUM trial was intended to compare the safety and effectiveness of Ojjaara and danazol in treating and reducing the main symptoms of myelofibrosis in a population that had previously used a JAK inhibitor and was anaemic.
The trial demonstrated statistically significant improvement in constitutional symptoms, splenic response, and transfusion independence in patients treated with momelotinib versus danazol, meeting all its primary and important secondary goals.
SIMPLIFY-1 was designed to compare the effectiveness and safety of ACVR1 inhibitor, which was acquired by GSK via the acquisition of Sierra Oncology last year, and ruxolitinib in patients with myelofibrosis who had never received JAK-inhibitor therapy.
A subset of individuals with anaemia served as the basis for the safety and efficacy outcomes for SIMPLIFY-1, the British pharmaceutical firm said.
GSK Oncology Global Product Strategy SVP Nina Mojas said: “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.”
MOMENTUM was a late-stage, global, multicentre, randomised, double-blind study to assess the safety and efficacy of momelotinib for treating and reducing key hallmarks of the disease.
SIMPLIFY-1 was a multicentre, randomised, double-blind study intended to evaluate the safety and efficacy of Ojjaara to ruxolitinib in myelofibrosis patients with no prior therapy with a JAK inhibitor.