SNY's Rilzabrutinib Gets FDA's Orphan Drug Tag for Two Rare Diseases

Sanofi (SNY) announced that the FDA has granted orphan drug designation to its investigational BTK inhibitor, rilzabrutinib, for the treatment of warm autoimmune hemolytic anemia (wAIHA) and IgG4-related disease (IgG4-RD).The candidate is being developed in separate mid-stage studies for treating wAIHA and IgG4-RD, two rare diseases.Currently, there are no approved therapies for treating wAIHA and IgG4-RD. Both diseases have a significant unmet medical need.The FDA grants orphan drug designation to support ...