A Historic Milestone: FDA Approves Lisraya/brepocitinib for Myositis

The myositis community has reached a significant new treatment milestone.

On August 27, 2026, the U.S. Food and Drug Administration approved Lisraya (brepocitinib) for adults with dermatomyositis. Lisraya is the first FDA-approved oral treatment specifically indicated for dermatomyositis and the first JAK inhibitor approved for the disease.

For people living with myositis, this represents an important shift. For decades, treatment has relied heavily on corticosteroids and other medications that were not developed specifically for dermatomyositis. Lisraya works differently, targeting immune pathways involved in the disease.

The trial that supported the approval showed improvements across measures of dermatomyositis disease activity, and patients receiving Lisraya were more likely to reduce their use of corticosteroids.

“This approval represents a major milestone for the entire myositis community and an important step toward a new era of treatment,” said Jim Minow, Executive Director of Cure JM. “For our families, the goal is simple: more effective treatment options and less reliance on steroids over time. We are proud to be partnering with Priovant as we move into the next phase of this work for juvenile myositis.”

Cure JM families have followed the promise of JAK inhibitors and the development of brepocitinib for several years. Adult approval represents an important first step.

Cure JM looks forward to sharing information on the next phase leading to pediatric approval, and as clinicians and researchers continue to help families understand how Lisraya may be a benefit to individual patients.

Thank you to all families whose support has made this milestone possible.

For More Information From the Experts

Families interested in learning more about JAK inhibitors and what this progress could mean for juvenile myositis are encouraged to join Cure JM on Wednesday, September 16, for our upcoming Town Hall, What New JAK Treatment Breakthroughs Mean for Juvenile Myositis, where you’ll hear directly from Dr. Dawn Wahezi.

REGISTER FOR THE JAK INHIBITORS TOWN HALL

Resources

Read the FDA announcement

Read the Priovant annoucement

Explore Clinical Trials in Juvenile Myositis

This information is provided for educational purposes and is not a substitute for medical advice from a qualified healthcare professional.

Clinician's September Summit 2024

Cure JM September 2024 – Virtual Summit

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June 2026 Town Hall

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On June 16, Cure JM’s Shannon Malloy sat down with Tania Gonzalez Rivera, VP of Medical Affairs, and Courtney Little, Senior Director and Clinical Scientist

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