J&J Receives FDA Fast Track Designation For Nipocalimab For Moderate-to-Severe Sjögren's Disease

(RTTNews) - Johnson & Johnson (JNJ) announced Tuesday that the U.S. Food and Drug Administration (FDA) has granted investigational nipocalimab Fast Track designation (FTD) for the treatment of adult patients with moderate-to-severe Sjogren'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.

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%.

The trends of improvement were similarly observed across multiple secondary endpoints. Safety and tolerability were consistent with other nipocalimab clinical studies.