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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