GSK Reports the US FDA’s Acceptance of NDA for Momelotinib to Treat Myelofibrosis
Shots:
- The US FDA has accepted the NDA for momelotinib to treat patients with myelofibrosis associated with anaemia. The PDUFA date is expected on 16 June 2023
- The NDA was based on the results from P-III (MOMENTUM) trial to evaluate the safety and efficacy of momelotinib vs danazol in a ratio (2:1) in 195 patients with myelofibrosis who were symptomatic and anaemic and prior treated with an FDA-approved JAK inhibitor across 21 countries
- The trial met 1EPs & 2EPs i.e., the therapy showed a ≥50% reduction in TSS over 28 days before the end of 24wk. over baseline TSS by using MFSAF while TI rate for ≥12wks. with Hb levels ≥ 8 g/dL and SRR based on splenic volume reduction of ≥35% @24wks. from baseline
Ref: GSK | Image: GSK
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