GSK Receives the US FDA’s Approval of Ojjaara (momelotinib) for Myelofibrosis Patients with Anemia
- The US FDA has approved Ojjaara for intermediate or high-risk myelofibrosis, incl. primary myelofibrosis or secondary myelofibrosis (post-polycythemia vera & post-essential thrombocythemia) in adults with anemia
- The approval was based on the P-III trial (MOMENTUM) & data for a subpopulation of adult patients with anemia from the P-III (SIMPLIFY-1) trial evaluating momelotinib. The (MOMENTUM) trial met all 1EPs & 2EPs and demonstrated significant improvements in myelofibrosis-associated symptoms, anemia measures, and spleen response with favorable safety over danazol
- In (SIMPLIFY-1), momelotinib showed noninferiority to ruxolitinib in spleen volume response at a reduction of ≥35% as well as improvement in transfusion dependence rates
Ref: GSK | Image: GSK
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