Health Canada Approves GSK's Ojjaara (momelotinib) for Myelofibrosis with Anemia

Key Insights

• Health Canada has approved GSK's Ojjaara (momelotinib) for treating myelofibrosis (MF) in adult patients with moderate-to-severe anemia.
• The approval is based on Phase III MOMENTUM trial data, which showed improvements in symptom score, transfusion independence, and splenic response rate compared to danazol.
• Ojjaara, a once-daily oral treatment, is indicated for intermediate or high-risk primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF.

Health Canada has approved GlaxoSmithKline's (GSK) Ojjaara (momelotinib) for the treatment of myelofibrosis (MF) in adult patients who have moderate-to-severe anemia. This approval marks a significant advancement in the treatment landscape for MF patients in Canada, offering a new therapeutic option to address the challenges of anemia associated with the disease.

The approval is specifically for patients with intermediate or high-risk primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF. Ojjaara is administered orally once daily.

The approval is based on data from the Phase III MOMENTUM trial, a global, randomized, multicenter, double-blind study that compared momelotinib with danazol in symptomatic and anemic MF patients previously treated with a Janus kinase (JAK) inhibitor. The trial assessed the efficacy and safety of momelotinib in managing symptoms, reducing blood transfusion needs, and decreasing spleen enlargement.

The MOMENTUM trial demonstrated that Ojjaara led to significant improvements in total symptom score (TSS), transfusion independence (TI), and splenic response rate (SRR) compared to danazol. These findings highlight the potential of momelotinib to address multiple key aspects of myelofibrosis.

Further supporting the approval is data from a patient subset in the Phase III SIMPLIFY-1 trial, which also demonstrated Ojjaara’s efficacy in treating MF patients with moderate-to-severe anemia and related symptoms. In September of the previous year, the U.S. Food and Drug Administration (FDA) approved Ojjaara for the same indication.

Michelle Horn, Interim Country Medical Director at GSK Canada, stated that treatment options for myelofibrosis-related anemia have been limited, and this approval represents a significant milestone to improve patient outcomes. She also highlighted GSK’s commitment to making an impact in Canada’s hematology oncology space through innovative new treatments.

GSK acquired Ojjaara through its acquisition of Sierra Oncology in 2022. The drug's approval offers a valuable treatment alternative for Canadian patients, addressing a critical unmet need and improving outcomes for those suffering from myelofibrosis-related anemia.