- Johnson & Johnson (NYSE:JNJ) announced Monday that its experimental antibody therapy nipocalimab generated positive results in two clinical trials for autoimmune conditions, generalized myasthenia gravis and Sjögren’s disease.
- Citing topline data, the New Brunswick, New Jersey-based pharma giant said nipocalimab reached the primary endpoint in its pivotal Phase 3 study, VIVACITY for gMG, and Phase 2 DAHLIAS study in adults with SjD.
- The company said that Nipocalimab, a monoclonal antibody designed to block neonatal Fc receptor (FcRn), indicated a well-tolerated safety profile in both trials.
- Johnson & Johnson (JNJ) plans to present complete VIVACITY data at an upcoming medical conference and submit the findings to global regulators seeking approval for nipocalimab in gMG.
- It expects to guide its future clinical studies for the drug in SjD based on DAHLIAS data and plans to present full trial data this year at a medical event.
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