Health Canada has granted approval for GlaxoSmithKline’s (GSK) Ojjaara (momelotinib) for treating myelofibrosis (MF) in adults with moderate-to-severe anaemia.
The once-daily, oral treatment is indicated for use in patients with intermediate or high-risk primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF.
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This approval is based on the results from the global, randomised, multicentre, double-blind Phase III MOMENTUM trial of Ojjaara.
The trial compared momelotinib with danazol in symptomatic and anaemic MF patients who had previously received treatment with an approved Janus kinase inhibitor.
It assessed the safety and efficacy of momelotinib in addressing various aspects of the disease, including symptom relief, reduction in blood transfusions required for anaemia, and decrease in spleen enlargement.
According to the trial’s findings, Ojjaara treatment offered improvements in total symptom score, transfusion independence, and splenic response rate.
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By GlobalDataThe approval in Canada is also backed by further data from a patient subset in the Phase III SIMPLIFY-1 trial, which demonstrated Ojjaara’s efficacy in treating MF patients with moderate-to-severe anaemia and related symptoms.
In September last year, the US Food and Drug Administration approved Ojjaara for the same indication.
Initially developed by Sierra Oncology, GSK added Ojjaara to its portfolio through the acquisition of Sierra in 2022.
GSK Canada interim country medical director Michelle Horn said: “Treatment options for myelofibrosis-related anaemia have been limited. We are proud to offer this treatment alternative for Canadian patients to address this critical unmet need and other myelofibrosis symptoms.
“With most myelofibrosis patients becoming anaemic 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 haematology oncology space through innovative new treatments.”
