Shots:
- The approval was supported by the P-III (MycarinG) study evaluating the safety, efficacy & tolerability of Rystiggo (7 or 10mg/kg) vs PBO in gMG patients. The 1EP of the study includes a change in MG-ADL score at Day43 & 2EPs include a change in MG-C score, QMG, patient-reported outcomes at Day43 and AEs
- The trial depicted clinically meaningful & statistically significant improvement in gMG-specific outcome vs PBO as reduction in MG-ADL scores from baseline to Day43 were greater with both doses vs PBO
- Rystiggo, humanized mAb that specifically binds to human FcRn, received the EU’s ODD in 2020 for gMG. The approval came following the US FDA & MHLW’s approval for Rystiggo & Zilbrysq & EC’s approval for UCB’s Zilbrysq in 2023
Ref: UCB | Image: UCB| Press Release
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