JnJ Nipocalimab gets USFDA Fast Track designation for Sjogren's disease
Spring House: Johnson & Johnson has received Fast Track designation (FTD) from the U.S. Food and Drug Administration (FDA) for investigational nipocalimab for the treatment of adult patients with moderate-to-severe Sjögren’s disease (SjD), having previously been granted Breakthrough Therapy designation (BTD) for the investigational therapy late last year.
Currently, no advanced therapies are approved to treat this disease.
Building upon the BTD, which nipocalimab is the first and only therapeutic to receive for SjD, the U.S. FDA’s FTD is also designed to accelerate the delivery of new therapeutics to patients by facilitating the development and expediting the review of drugs that demonstrate the potential to treat serious conditions and help address unmet needs for serious or life-threatening conditions.
“This marks an additional important step forward in our efforts to bring meaningful advancements to people living with Sjögren’s disease, a serious and debilitating condition. We look forward to continuing to work closely with the FDA to advance the clinical development of nipocalimab and potentially provide a much-needed treatment option for this community,” said Katie Abouzahr, M.D., Vice President, Autoantibody Portfolio and Maternal Fetal Disease Area Leader, Johnson & Johnson Innovative Medicine.
There are no FDA-approved treatments that directly address the underlying causes of this complex disease, associated with serious health consequences including chronic dryness of moisture producing glands that may lead to systemic complications such as joint pain, fatigue and inflammation in multiple organ systems.1 These systemic complications can lead to an increased risk of mortality and associated health conditions, including a 20 times greater risk of developing B-cell lymphomas when compared to the general population.
The Phase 2 DAHLIAS study, the results of which were presented last year, represented the first-ever positive results of an investigational FcRn blocker as a potential targeted therapy in SjD. The study achieved the primary endpoint in the 15 mg/kg Q2W nipocalimab group, showing a greater than 70% relative average improvement in systemic disease activity at Week 24 compared to placebo and IgG reductions of more than 77%. Trends of improvement were similarly observed across multiple secondary endpoints. Safety and tolerability were consistent with other nipocalimab clinical studies.
Nipocalimab is an investigational monoclonal antibody, designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies potentially without impact on other immune functions. This includes autoantibodies and alloantibodies that underlie multiple conditions across three key segments in the autoantibody space including Rare Autoantibody diseases, Maternal Fetal diseases mediated by maternal alloantibodies and Rheumatic diseases. Blockade of IgG binding to FcRn in the placenta is also believed to limit transplacental transfer of maternal alloantibodies to the fetus.
The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab.
U.S. FDA granted Fast Track designation in hemolytic disease of the fetus and newborn (HDFN) and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021 and fetal neonatal alloimmune thrombocytopenia (FNAIT) in March 2024 and Sjögren’s disease (SjD) in March 2025.
U.S. FDA granted Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023.
U.S. FDA granted Breakthrough Therapy designation for HDFN in February 2024 and for Sjögren’s disease in November 2024.
U.S. FDA granted Priority Review in gMG in Q4 2024
EU EMA Orphan medicinal product designation was given for HDFN in October 2019.
