Priovant Therapeutics, formed by Roivant Sciences and Pfizer, received FDA approval for Lisraya (brepocitinib). The drug treats adults with dermatomyositis. This rare autoimmune disease causes muscle weakness and distinct skin rashes.
Lisraya is the first oral targeted therapy specifically approved for dermatomyositis. Historically, steroids and non-specific therapies treated the condition.
Pfizer originally discovered the drug. Lisraya is a once-daily pill. It inhibits TYK2 and JAK1, proteins involved in inflammatory responses.
The approval stems from the Phase 3 VALOR study. This study showed Lisraya-treated patients had significant improvements in muscle and skin disease compared to a placebo group. Pfizer holds a 25% equity stake in Priovant.