The FDA Grants Fast Track Designation To Johnson & Johnson's Nipocalimaba For Systemic Lupus Erythematosus

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  • Fast Track designation reflects the unmet need in this serious disease and enables the potential for an accelerated FDA review timeline
  • The designation is supported by a Phase 2 study in which nipocalimab demonstrated reduction in lupus disease activity and potential for steroid sparing
  • Systemic lupus erythematosus is a debilitating, chronic autoantibody-driven disease affecting multiple organs, with limited treatment options and risk of irreversible organ damage
  • Johnson & Johnson is actively enrolling patients in a Phase 3 study of adults with active systemic lupus erythematosus
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