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Janssen Presents Results of Nipocalimab (M281) in P-II Vivacity-MG Study for Adults with Generalized Myasthenia Gravis at AAN2021

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Janssen Presents Results of Nipocalimab (M281) in P-II Vivacity-MG Study for Adults with Generalized Myasthenia Gravis at AAN2021

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  • The P-II Vivacity-MG study involves assessing the safety- tolerability- efficacy- PK- PD- and immunogenicity of nipocalimab in addition to SoC vs PBO in a ratio (1:1:1:1:1) in 68 patients with gMG
  • The 1EPs of the study include safety- tolerability- and efficacy assessed by (MG-ADL) ADL score. The 2EPs includes the efficacy as measured by changes in QMG score and revised MG-QoL15 scale from baseline- PK- and PD activity as measured by effects on total serum IgG concentrations- safety and tolerability
  • Nipocalimab is a high affinity- fully human- aglycosylated- effectorless IgG1 anti-FcRn mAb and has been received ODD from US FDA for MG

  Ref: PR Newswire | Image: Janssen

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