Posted by Michael Wonder on 19 Mar 2025
Nipocalimab, the first and only investigational treatment to be granted US FDA breakthrough therapy designation for the treatment of adults with moderate to severe Sjögren’s disease, has now received fast track designation
18 March 2025 - This marks the fourth nipocalimab FDA fast track designation.
Johnson & Johnson today announced that the US FDA has granted investigational nipocalimab fast track designation for the treatment of adult patients with moderate to severe Sjögren’s disease, having previously been granted breakthrough therapy designation for the investigational therapy late last year.
