FDA approves oral dermatomyositis therapy - Takeaways - MDSpire

FDA approves oral dermatomyositis therapy

Phase 3 findings show improvements in physical function and skin disease activity.

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The FDA approved brepocitinib (Lisraya) tablets as the first oral treatment for adults with dermatomyositis.
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Brepocitinib is a once-daily oral Janus kinase and tyrosine kinase 2 inhibitor targeting immune and inflammatory pathways.
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The approval followed a phase 3 study involving 241 adults, assessing efficacy through the Total Improvement Score at week 52.
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Participants receiving brepocitinib 30 mg showed greater improvement in muscle strength, physical function, and skin disease activity.
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Brepocitinib has a boxed warning for serious infections, increased mortality, malignancies, and cardiovascular events.