Johnson & Johnson: FDA grants nipocalimab Breakthrough Therapy designation

Johnson & Johnson announced that the U.S. Food and Drug Administration has granted nipocalimab Breakthrough Therapy designation for the treatment of adults living with moderate-to-severe Sjogren’s disease, a debilitating and chronic autoantibody disease with high prevalence, for which no approved advanced treatments are available. 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.