GSK Reports the US FDA’s Acceptance of NDA for Momelotinib to Treat Myelofibrosis
- 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
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at email@example.com.