FDA Approval · August 27, 2026 · Dermatomyositis
Brepocitinib (Lisraya) FDA-Approved for Dermatomyositis â The First Oral Treatment for This Disease
Pfizer's brepocitinib (TYK2/JAK1 dual inhibitor) receives FDA approval for adult dermatomyositis after meeting its primary TIS endpoint and all 9 secondary endpoints in the VALOR trial â including muscle strength, skin disease, and functional status. It is the first oral therapy approved for any inflammatory myopathy. The mechanism targets type I interferon and IL-12/23 signaling directly, addressing the core immunopathology of dermatomyositis.
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