CANADA – Health Canada has approved GlaxoSmithKline’s (GSK) Ojjaara (momelotinib) for treating adults with moderate-to-severe anemia linked to myelofibrosis (MF), offering new hope for individuals living with this rare and chronic blood cancer.
Affecting approximately 1,400 to 2,177 Canadians, myelofibrosis interferes with the bone marrow’s ability to produce healthy blood cells due to excessive scarring.
This condition leads to debilitating symptoms, including fatigue, bone pain, weight loss, easy bleeding, shortness of breath, and a persistent feeling of abdominal fullness.
Ojjaara, an oral, once-daily tablet, is specifically indicated for patients with intermediate or high-risk forms of primary MF, as well as those with MF developing from post-polycythemia vera or post-essential thrombocythemia.
The approval is based on strong clinical evidence from the Phase III MOMENTUM trial, a randomized, double-blind, multicenter study.
This trial evaluated the efficacy and safety of momelotinib compared to danazol in myelofibrosis patients experiencing anemia and symptoms, who had already received treatment with a Janus kinase (JAK) inhibitor.
MOMENTUM showed that Ojjaara helped alleviate symptoms, reduce the need for blood transfusions, and decrease spleen enlargement, which are key challenges in managing myelofibrosis.
This Canadian approval also leverages data from the Phase III SIMPLIFY-1 trial, which assessed Ojjaara’s potential to improve outcomes in MF patients with moderate-to-severe anemia.
Ojjaara’s mechanism of action is unique: it inhibits three critical pathways—JAK1, JAK2, and ACVR1 (activin A receptor type 1)—each contributing to the regulation of blood production and inflammation in myelofibrosis.
By targeting these pathways, Ojjaara offers a novel approach to managing the disease and its symptoms.
Ojjaara was originally developed by Sierra Oncology, which GSK acquired in 2022, further expanding GSK’s portfolio of innovative therapies.
Last year, the U.S. Food and Drug Administration (FDA) approved Ojjaara for similar indications, marking its initial entry into the market for managing MF-related anemia.
Michelle Horn, Interim Country Medical Director of GSK Canada, highlighted the significant impact this new therapy could have for Canadian patients, stating, “Treatment options for myelofibrosis-related anemia have been limited. We are proud to offer this treatment alternative for Canadian patients to address this critical unmet need and other myelofibrosis symptoms.”
Horn added, “With most myelofibrosis patients becoming anemic over time, Ojjaara’s approval represents a significant milestone to improve the outcomes of these patients while also highlighting GSK’s commitment to making an impact in Canada’s hematology oncology space through innovative new treatments.”
With Health Canada’s green light, Ojjaara will soon be available to Canadian patients, marking a crucial advancement in the treatment of myelofibrosis and addressing a substantial need for effective therapies that enhance patients’ quality of life.
GSK anticipates broader global and vendor-specific regulatory clearances for Ojjaara through 2025.
