UCB Receives MHLW Approval of Rystiggo (rozanolixizumab) and Zilbrysq (zilucoplan) for Adult Patients with Generalized Myasthenia Gravis in Japan
Shots:
- The approval of rozanolixizumab was based on the P-III study (MycarinG) in 200 adult patients with gMG, which showed a reduction in MG-ADL score from baseline to Day 43 was greater in rozanolixizumab (7mg/kg) group and (10mg/kg group) vs PBO while secondary efficacy EPs incl. change from baseline to Day 43 in the QMG
- The approval of zilucoplan was based on the P-III study (RAISE) in 174 adult patients with anti-AChR Ab+ gMG, which showed a significant & clinical difference favoring zilucoplan over PBO in the MG-ADL & QMG total score change from baseline while 2EPs incl. change from baseline to 12wk. in QMG, MGC & MG-QoL15r
- Improvements in fatigue were reported as an exploratory EP. Both studies' results were published in The Lancet Neurology
Ref: Pharmiweb | Image: UCB
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