FDA Grants Fast Track Review To Johnson & Johnson's Nipocalimab For Autoimmune Disorder That Affects Tears, Saliva

The U.S. Food and Drug Administration granted on Tuesday Fast Track designation to Johnson & Johnson’s (NYSE:JNJ) investigational nipocalimab for moderate-to-severe Sjögren’s disease (SjD).

Last year, FDA granted Breakthrough Therapy designation (BTD) for the investigational therapy.

The Phase 2 DAHLIAS study, 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 ...