UCB Presents Efficacy and Safety Results of Zilucoplan and Rozanolixizumab in P-III (RAISE) & (MycarinG) Study for Generalized Myasthenia Gravis at MGFA 2022
Shots:
- The P-III (RAISE) study evaluates zilucoplan (0.3mg/kg, SC) in a ratio (1:1) in 174 patients & the P-III (MycarinG) study evaluates rozanolixizumab (7/10mg/kg) in 200 adults with gMG. The regulatory submissions are expected in 2022
- The (RAISE) study met its 1EPs & 2EPs i.e., mean improvement in MG-ADL score @12wk. along with other scores @1wk., safety profile & tolerability were consistent with prior data, TEAEs (76.7% vs 70.5%)
- In (MycarinG) study, reduction in MG-ADL from baseline to Day 43 at ~7/10mg/kg doses while ≥70% in IgG levels (71 %/78%), anti-AChR autoantibody levels decreased with total IgG reduction, TEAEs (81.3%/82.6% vs 67.2% for PBO), baseline characteristics were well balanced
Ref: UCB | Image: UCB
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