Johnson & Johnson Today Announces That The U.S. FDA Has Granted Nipocalimab Breakthrough Therapy Designation For The Treatment Of Adults Living With Moderate-To-Severe Sjögren's Disease, A Debilitating And Chronic Autoantibody Disease With High Prevalence, For Which No Approved Advanced Treatments Are Available

The Breakthrough Therapy Designation (BTD) for investigational nipocalimab in Sjögren's disease, a prevalent autoantibody disease with no approved advanced therapies, is supported by results from the Phase 2 DAHLIAS study

A greater than 70 percent relative improvement in systemic disease activity at Week 24 was demonstrated in study participants on average who received nipocalimab 15 mg/kg compared to participants who received placebo

Nipocalimab was granted BTD in hemolytic disease of the fetus and newborn earlier this year, making this the second time Johnson & Johnson's nipocalimab has received this designation

SPRING HOUSE, Pa., Nov. 11, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced that the U.S. Food and Drug Administration (FDA) has granted nipocalimab Breakthrough Therapy designation (BTD) for the treatment of adults living with moderate-to-severe Sjögren's disease (SjD), a debilitating and chronic autoantibody disease with high prevalence, for which no approved advanced treatments are available.1,2,3,4 Nipocalimab is the only investigational therapy to secure this designation in SjD. This regulatory milestone is the second time BTD has been granted for nipocalimab; the first was granted in February for the treatment of alloimmunized pregnant individuals at high risk of severe hemolytic disease of the fetus and newborn (HDFN).