Shots:
The CHMP has recommended Nipocalimab as an add-on therapy to treat anti-AChR Ab+ & anti-MuSK Ab+ gMG pts (≥12yrs.)
Opinion was based on the P-III (Vivacity-MG3) trial assessing nipocalimab (30mg/kg, IV loading dose then 15mg/kg, Q2W) + SoC vs PBO + SoC in gMG pts (N=199; 153 were Ab +ve), which showed improved MG-ADL score…
Shots:
The US FDA has approved Imaavy to treat antibody +ve gMG pts (≥12yrs.) under priority review based on the ongoing P-III (Vivacity-MG3) trial assessing Imaavy + SoC vs PBO + SoC in antibody +ve or -ve adults (N=199; 153 were Ab +ve); global regulatory review is ongoing
Trial showed superior disease control per MG-ADL…
Shots:
J&J has reported additional findings from P-III (Vivacity-MG3) trial & ongoing OLE assessing nipocalimab + SoC (30mg/kg, IV loading dose followed by 15mg/kg, Q2W) vs PBO in anti-AChR+, anti-MuSK+ & anti-LRP4+ adults (n=153) with gMG
Trial showed a -4.9 QMG score improvement over 22 & 24wks. & pts were 4x more likely to sustain…

