> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# First Oral Drug Indicated to Treat Dermatomyositis Approved
- URL: https://www.fdaweb.com/first-oral-drug-indicated-to-treat-dermatomyositis-approved/
- Published: 2026-08-28T12:00:00.000Z
- Updated: 2026-09-14T12:05:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161704

FDA has approved Priovant Therapeutics’ Lisraya (brepocitinib) tablets for treating dermatomyositis in adults. “For too long, patients with dermatomyositis have faced a significant unmet need for effective treatments, often relying on therapies meant for other diseases,” FDA says in a release. “Dermatomyositis is a rare autoimmune disease in which the immune system attacks the muscles and skin, causing chronic inflammation, progressive muscle weakness, and distinctive skin rashes.”

The Janus kinase (JAK/TYK2) inhibitor works by blocking JAK pathways, which play a key role in the body's immune and inflammatory responses, thus reducing harmful inflammation that damages muscles and skin, the agency says.

The study measured Total Improvement Score (TIS) at week 52, a standardized scoring tool that tracks changes across six areas (muscle strength, physical function, skin and other disease activity, muscle enzymes, and both physician and patient assessments of overall health) to assess how much a patient’s dermatomyositis has improved.

Participants treated with Lisraya 30 mg had a higher average Total Improvement Score (indicating greater clinical response and disease control) at week 52 compared to those taking a placebo, according to FDA. They also showed improvements in physical function and skin disease activity and were more likely to reduce corticosteroid use by week 48.