Shots:
- The EC has approved Imaavy (nipocalimab) as an add-on therapy to treat anti-AChR or anti-MuSK antibody-positive gMG pts (≥12yrs.)
- Approval was based on the P-III (Vivacity-MG3) trial assessing Imaavy (30mg/kg, IV loading dose then 15mg/kg, Q2W) + SoC (n=77) vs PBO + SoC (n=76) in gMG pts (N=199; 153 were Ab +ve), which showed improved MG-ADL score over 24wks. (1EP), sustained for another ~20wks. in the OLE phase
- Approval also incl. data from P-II/III (Vibrance-MG) pediatric trial (N=7), which met its 1EP of reduced IgG levels with Imaavy + SoC over 24wks. & achieved its 2EPs of improved MG-ADL & QMG scores
Ref: GlobeNewswire | Image: Johnson & Johnson | Press Release
Related News: Johnson & Johnson’s Tremfya (Guselkumab) Receives the US FDA’s Approval for Pediatric Plaque Psoriasis and Active Psoriatic Arthritis
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