Nipocalimab

Nipocalimab, a drug in development for myasthenia gravis, showed promise in treating primary Sjögren's syndrome, with significant improvement in ESSDAI scores compared to placebo at 15 mg/kg every 2 weeks. A phase III study is planned. The drug targets FcRn to reduce IgG levels, with no safety concerns reported in the trial.

Johnson & Johnson's nipocalimab granted FDA breakthrough therapy designation for treating moderate to severe Sjögren’s disease, based on Phase 2 DAHLIAS trial results showing a 70% reduction in systemic disease activity at 24 weeks with the 15 mg/kg dose. Nipocalimab, designed to block FcRn and reduce IgGs, is the first antibody therapy to show positive Phase 2 results in Sjögren’s patients, with no current disease-modifying treatments available.

Johnson & Johnson's nipocalimab receives FDA Breakthrough Therapy designation for treating moderate-to-severe Sjögren’s disease, based on Phase 2 DAHLIAS study results showing over 70% improvement in systemic disease activity. This marks the first investigational therapy for SjD to receive such designation, highlighting the need for innovative treatments in this chronic autoantibody disease.

Johnson & Johnson's Phase II DAHLIAS study of nipocalimab, an FcRn blocker, showed promising results in treating moderate-to-severe Sjögren’s disease, meeting primary and secondary endpoints, with significant improvements in ClinESSDAI scores and symptom relief.

Nipocalimab, an FcRn blocker, showed significant improvements in disease activity scores and IgG reductions in adults with moderate-to-severe Sjögren's disease after 24 weeks of treatment, according to the Phase 2 DAHLIAS study. The FDA granted Breakthrough Therapy Designation for nipocalimab based on these results.

J&J's nipocalimab granted breakthrough therapy designation by FDA for treating moderate-to-severe Sjögren’s disease, supported by positive DAHLIAS study results showing significant improvement in ClinESSDAI score at 24 weeks.

Johnson & Johnson announced FDA's Breakthrough Therapy designation for nipocalimab in treating moderate-to-severe Sjögren's disease, a chronic autoantibody disease with no advanced treatments. Nipocalimab is the first FcRn blocker to show positive results in a phase 2 study for this condition, with a phase 3 study underway. The FDA grants BTD to expedite development of medicines for serious conditions with substantial improvement potential.

FDA grants breakthrough therapy designation to nipocalimab for treating moderate to severe Sjögren’s disease, marking the first such designation for the condition.

The FDA awarded Johnson & Johnson's nipocalimab a breakthrough therapy designation for treating moderate-to-severe Sjögren’s disease, based on Phase II DAHLIAS study data. Nipocalimab is the first investigational FcRn blocker to show positive results in SjD, aiming to address the disease's underlying causes.

FDA grants breakthrough therapy designation to nipocalimab for treating moderate-to-severe Sjogren's disease, a chronic autoimmune disorder with no current treatments addressing its cause. A phase 3 study is underway based on phase 2 data.