- Lisraya is a once-daily JAK/TYK2 inhibitor and the first FDA-approved oral treatment option for adults with dermatomyositis, a rare autoimmune disease.
- In a 241-patient Phase 3 trial, the 30 mg dose delivered a higher average Total Improvement Score at week 52 than placebo and improved physical function and skin disease activity.
- The drug carries a boxed warning covering serious infections, all-cause mortality, malignancies, major adverse cardiovascular events and thrombosis.
Quotes
“Today’s approval is a meaningful step forward, giving patients and their healthcare providers an approved oral therapy proven to help manage this rare and debilitating disease.”