3 Topic Commentaries

FDA approves oral dermatomyositis therapy

• 

  Nikolay Nikolov, MD

  Immunology

  •

  U.S. Food and Drug Administration

  “For too long, patients with dermatomyositis have faced a significant unmet need for effective treatments, often relying on therapies meant for other diseases,” said Nikolay Nikolov, M.D., Director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research. “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.”

  Source
• 

  Rohit Aggarwal, MD, MS

  Rheumatology

  •

  University of Pittsburgh School of Medicine

  “Dermatomyositis has long been one of the most challenging diseases to manage, often robbing patients of their mobility, independence, and quality of life,” noted Aggarwal. “The VALOR trial results signal a turning point. Brepocitinib has the potential to transform how we care for these patients, moving us away from broad immunosuppression and steroid dependence toward therapies that precisely target the immune pathways driving the disease.”

  Source
• 

  Ruth Ann Vleugels, MD, MPH, MBA

  Dermatology

  •

  Harvard Medical School

  “Brepocitinib is a first-in-class, selective TYK2–JAK1 inhibitor, a mechanistic profile that maps closely to pathways strongly implicated in dermatomyositis biology,” explains Ruth Ann Vleugels, co-corresponding author of the paper reporting the results.

  Source