Health Canada approves GSK's Ojjaara for anaemic myelofibrosis patients

Health Canada has approved GlaxoSmithKline’s (GSK) Ojjaara (momelotinib) for treating myelofibrosis (MF) in adults experiencing moderate-to-severe anemia. This medication, taken once daily in oral form, targets patients with intermediate or high-risk primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF.

The approval is rooted in the comprehensive results from the global, randomized, multicenter, double-blind Phase III MOMENTUM trial. This trial compared momelotinib with danazol in symptomatic and anemic MF patients who had previously received treatment with a Janus kinase inhibitor. The study aimed to evaluate the safety and efficacy of momelotinib by examining various disease aspects, including symptom relief, reduction in the need for blood transfusions due to anemia, and spleen size reduction.

The findings from the MOMENTUM trial indicated that Ojjaara treatment led to significant improvements in total symptom score, achieving transfusion independence, and a positive splenic response rate. Additionally, the approval in Canada is supported by further data from a subset of patients in the Phase III SIMPLIFY-1 trial, which highlighted Ojjaara’s effectiveness in treating MF patients with moderate-to-severe anemia and related symptoms.

Furthermore, in September of the previous year, the US Food and Drug Administration (FDA) also approved Ojjaara for the same indication. Originally developed by Sierra Oncology, Ojjaara became a part of GSK’s portfolio following the acquisition of Sierra in 2022.

Michelle Horn, the interim country medical director for GSK Canada, expressed the significance of this approval. She emphasized that treatment options for myelofibrosis-related anemia have been limited and that they are proud to offer a new treatment alternative for Canadian patients to address this critical unmet need and other myelofibrosis symptoms. Horn noted the importance of this milestone, as most myelofibrosis patients develop anemia over time. She highlighted that Ojjaara’s approval marks a significant step forward in improving patient outcomes and underscores GSK’s commitment to advancing haematology oncology treatments in Canada.