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 over 24wks. (1EP), sustained for ~84wks. in the OLE phase
- Recommendation also incl. data from P-II/III (Vibrance-MG) pediatric trial, which met its 1EP of reduced IgG levels with nipocalimab (IV, Q2W), & achieved its 2EPs of improved MG-ADL & QMG scores
Ref: Johnson & Johnson | Image: Johnson & Johnson | Press Release
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