SPRING HOUSE, PA — Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to nipocalimab for treating adults with moderate-to-severe Sjögren’s disease (SjD). This is a significant milestone as nipocalimab is the first investigational therapy to receive this designation for SjD, a chronic autoantibody disease with no advanced treatments currently approved.
The designation is based on promising results from the Phase 2 DAHLIAS study, which demonstrated that patients receiving nipocalimab showed more than a 70% improvement in systemic disease activity at Week 24 compared to those on a placebo. These findings highlight nipocalimab’s potential as a targeted therapy for SjD, a disease that affects glands producing saliva and tears, and can cause systemic issues affecting multiple organs.
“This announcement marks an important step forward in the continued research and development of nipocalimab,” said Terence Rooney, Vice President, Rheumatology, Immunology Disease Area Leader at Johnson & Johnson Innovative Medicine. He emphasized the need for innovation in SjD treatments, stating, “With no treatments currently approved that may directly address the underlying cause(s) of the disease, innovation is critically needed to improve patient outcomes in Sjögren’s disease.”
The FDA’s Breakthrough Therapy designation aims to expedite the development and review of drugs that show substantial improvement over existing treatments for serious or life-threatening conditions. This is the second time nipocalimab has received this designation, the first being for the treatment of hemolytic disease of the fetus and newborn earlier this year.
Johnson & Johnson is continuing to evaluate nipocalimab through a Phase 3 study, building on the Phase 2 results presented at the European Alliance of Associations for Rheumatology Congress. The ongoing research aims to bring a novel treatment option to patients with SjD, who face significant health challenges and risks associated with the disease.
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