Health Canada approves GSK’s Ojjaara for anaemia in myelofibrosis

CANADA—Canada’s health regulatory body, Health Canada, has approved GlaxoSmithKline’s (GSK) Ojjaara (momelotinib) for the treatment of myelofibrosis (MF) in adults with moderate-to-severe anaemia.

 This once-daily oral medication is specifically indicated for patients with intermediate or high-risk primary MF and those with post-polycythemia vera MF or post-essential thrombocythemia MF.

The approval is based on data from the global, randomized, double-blind Phase III MOMENTUM trial, which investigated the efficacy of Ojjaara in comparison to danazol.

This study focused on patients with symptomatic, anaemic MF who had previously been treated with a Janus kinase (JAK) inhibitor.

Researchers looked at various aspects of treatment effectiveness, including relief from symptoms, reduced need for blood transfusions, and decreased spleen enlargement, a common complication of MF.

The results were promising, showing that Ojjaara significantly improved the total symptom score, transfusion independence, and spleen response rate in patients.

Additionally, data from the Phase III SIMPLIFY-1 trial further supported the approval, demonstrating Ojjaara’s ability to effectively treat MF patients with moderate-to-severe anaemia and related symptoms.

Ojjaara’s approval in Canada comes after its approval by the US Food and Drug Administration (FDA) in September of the previous year.

Initially developed by Sierra Oncology, the treatment was added to GSK’s portfolio when the company acquired Sierra in 2022.

Michelle Horn, interim country medical director at GSK Canada, emphasized the importance of this approval, as treatment options for anaemia related to myelofibrosis have historically been limited.

She expressed pride in offering this new treatment option to Canadian patients, especially since many myelofibrosis patients develop anaemia over time.

Horn highlighted that Ojjaara’s approval is crucial to improving patient outcomes and addressing the significant unmet needs of those suffering from MF symptoms.

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