UCB Receives the EMA’s CHMP Positive Opinion Recommending Marketing Authorization of Zilucoplan for Adults with Generalized Myasthenia Gravis
Shots:
- The opinion was based on the P-III study (RAISE) evaluating zilucoplan (0.3mg/kg, SC) vs PBO in a ratio (1:1) in adult patients with AChR Ab+ gMG which showed improvements in gMG-specific efficacy outcomes, significant and clinical difference favoring zilucoplan was observed in the MG-ADL total score change from baseline
- The 2EPs incl. a change from baseline to 12wk. in QMG, MGC, and MG-QoL15r., significant & clinical difference was seen in QMG total score change from baseline to 12wk. The results were published in the Lancet Neurology journal
- Zilucoplan is currently under review by PMDA, US FDA, TGA & Health Canada for gMG. Responses from the PMDA & US FDA are expected at the end of Q4 2023; from TGA & Health Canada are expected by H1’24
Ref: UCB | Image: UCB
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