Nipocalimab

Johnson & Johnson announced FDA's Breakthrough Therapy designation for nipocalimab in treating moderate-to-severe Sjögren's disease, supported by Phase 2 DAHLIAS study data. This marks the second BTD for nipocalimab, following one for high-risk pregnant individuals in February. The designation aims to expedite development and review of potential therapies for serious conditions.

Johnson & Johnson's nipocalimab receives breakthrough therapy designation from FDA for treating moderate-to-severe Sjögren's disease, a chronic autoimmune disorder with no current treatments addressing its underlying cause.

Johnson & Johnson announced FDA's Breakthrough Therapy designation for nipocalimab in treating moderate-to-severe Sjögren's disease, based on Phase 2 DAHLIAS study results showing a 70% improvement in systemic disease activity. This is the second BTD for nipocalimab, with the first for hemolytic disease of the fetus and newborn. The designation aims to expedite development and review of drugs for serious conditions, highlighting J&J's commitment to innovative treatments for autoantibody-driven diseases.

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FDA grants nipocalimab Breakthrough Therapy designation for Sjögren's disease, supported by Phase 2 DAHLIAS study results showing a 70% improvement in systemic disease activity at Week 24 with nipocalimab 15 mg/kg compared to placebo. This is the second BTD for nipocalimab, previously granted for hemolytic disease of the fetus and newborn.

Nipocalimab receives FDA Breakthrough Therapy designation for treating moderate-to-severe Sjögren’s disease, marking the first such designation for this condition. The decision is supported by Phase 2 DAHLIAS study data, which showed positive results for nipocalimab as a potential therapy.

The VIBRANCE-MG study (NCT05265273) demonstrated nipocalimab's safety and efficacy in adolescents with generalized myasthenia gravis (gMG), with significant reduction in total serum IgG and improvements in MG-ADL and QMG scores. Nipocalimab was well-tolerated, with no serious adverse events reported.

Nipocalimab plus standard of care showed sustained IgG reduction and safety in adolescents with generalized myasthenia gravis (gMG) in the Vibrance-MG study, with no serious adverse events reported.

Nipocalimab, a monoclonal antibody, showed promising results in the phase 3 VIVACITY-MG3 trial for generalized myasthenia gravis (gMG), meeting primary and secondary endpoints with a rapid and maintained reduction in MG-ADL scores. The treatment was well-tolerated with no new safety signals. Presented at the 2024 AANEM meeting, the study highlights nipocalimab's potential as a steady, IV-administered option for gMG, contrasting with currently available cyclical treatments.