Sanofi Receives FDA Approval for Rilzabrutinib in Pemphigus Vulgaris

Sanofi today announced that the FDA has approved rilzabrutinib for the treatment of adults with pemphigus vulgaris (PV). This marks the first oral BTK inhibitor approved for PV, a rare autoimmune blistering skin disease. In the Phase 3 PEGASUS trial, rilzabrutinib demonstrated a statistically significant improvement in complete remission rate compared to placebo. Rilzabrutinib is an oral, reversible BTK inhibitor that targets B cells and mast cells involved in PV pathophysiology. This approval provides patients with a new convenient oral treatment option.