Pharmaceutical company Johnson & Johnson (NYSE: JNJ) announced on Monday that it has received Breakthrough Therapy designation (BTD) from the US Food and Drug Administration (FDA) for nipocalimab for the treatment of adults living with moderate-to-severe Sjogren's disease (SjD), a debilitating and chronic autoantibody disease with high prevalence, for which no approved advanced treatments are available.

According to Johnson & Johnson, nipocalimab is the only investigational therapy to receive this designation in SjD. It is the second time BTD has been granted for nipocalimab.

The BTD is supported by data from the Phase 2 DAHLIAS study evaluating the efficacy and safety of nipocalimab for the treatment of adult patients with moderate-to-severe SjD and supports further evaluation of the investigational treatment through a Phase 3 study, which is underway. Data from the nipocalimab Phase 2 DAHLIAS study featured in a late-breaking oral presentation at the European Alliance of Associations for Rheumatology (EULAR) 2024 Congress and demonstrated the first-ever positive results of an investigational FcRn blocker as a potential targeted therapy in SjD.

Terence Rooney, vice president, Rheumatology, Immunology Disease Area leader at Johnson & Johnson Innovative Medicine, said: "Today's announcement marks an important step forward in the continued research and development of nipocalimab, the first investigational FcRn blocker to demonstrate positive results in a Phase 2 study in adult patients with moderate-to-severe Sjögren's disease. 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. This milestone underscores our unwavering commitment to develop novel, transformational therapies that may help address significant unmet need for patients living with autoantibody-driven diseases."