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Fedratinib has been approved by Health Canada for the treatment of myelofibrosis
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It has been announced that fedratinib, a pyrimidine-based Janus kinase 2 (JAK2) inhibitor, has been granted approval by Health Canada for the treatment of adult patients who have a large spleen size and show symptoms due to intermediate-2 or high-risk primary myelofibrosis (MF), post-polycythemia vera MF, or post-essential thrombocythemia MF. The approval was based on favorable results of phase III JAKARTA and JAKARTA2 trials.
Fedratinib had been previously approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with intermediate-2 or high-risk primary or secondary MF in August 2019, and its marketing authorization status is currently being assessed by the European Medicines Agency (EMA).
The MPN Hub has provided a summary of the long drug development journey of fedratinib here.
- Yahoo Finance. Health Canada approves INREBIC® (fedratinib), first new treatment in nearly a decade for patients living with myelofibrosis. https://finance.yahoo.com/news/health-canada-approves-inrebic-fedratinib-110000329.html Published Sep 21, 2020. Accessed Sep 22, 2020.
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