India, March 18 -- 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 s...