UCB Reports the US FDA Acceptance of NDA and EMA’s Validation of MAA for Zilucoplan to Treat Generalized Myasthenia Gravis
Shots:
- The US FDA has accepted the NDA of zilucoplan for review in adult patients with AChR-Ab+ gMG along with EMA validation of MAA. All patients continued in (RAISE-XT) OLE study, upon completion of 12wk. treatment period
- The NDA & MAA were based on the P-III (RAISE) study evaluating zilucoplan (0.3mg/kg, qd) vs PBO in 174 patients. The study met its 1EPs of mean improvement of 2.09 points in MG-ADL score @12wk., favorable safety & tolerability profile which showed a similar rate of TEAEs (76.7% vs 70.5%)
- Low rates of treatment discontinuation due to a TEAE. The 2EPs incl. change in QMG score, MGC & the MG-QoL15r score from baseline to 12wk, time to rescue therapy, the proportion of patients with MS; ≥3-point reduction in MG-ADL; ≥5-point in QMG without rescue therapy @12wk.
Ref: PRNewswire | Image: UCB
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