GSK Reports the Japanese MHLW’s Approval of Omjjara (momelotinib) for Treating Myelofibrosis
Shots:
- The approval was supported by two myelofibrosis P-III studies of Omjjara (JAK1/JAK2 & ACVR1 inhibitor, QD, oral) vs danazol in symptomatic & anemic patients (n=195) treated with a JAK inhibitor across MOMENTUM trial & Omjjara vs ruxolitinib in those not treated with a JAK inhibitor across SIMPLIFY-1 trial
- MOMENTUM study reached the 1EPs & 2EPs, showing a ≥50% reduced total symptom score (25% vs 9%) & ≥35% reduced spleen volume (22% vs 3%) with no transfusions & all hemoglobin values ≥8g/dL in the 12wks. before wk.24 (30% vs 20%)
- SIMPLIFY-1 study reached its 1EPs, depicting the superiority of Omjjara with a ≥35% reduced spleen volume (difference: 9%) & improved transfusion independence rates of 66.5% vs 49.3% (difference: 18%)
Ref: GSK | Image: GSK
Related News:- The European Commission Approves GSK’s Omjjara (momelotinib) for the Treatment of Severe Anaemia
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
