---
title: "FDA Approves Lisraya (brepocitinib) — First Oral Treatment for Adult Dermatomyositis"
id: "fda-news-releases-0-fda-approves-first-oral-drug-indicated-to-treat-dermatomyositis-in-adults"
canonical_url: "https://medichelpline.com/clinical-feed/fda-news-releases-0-fda-approves-first-oral-drug-indicated-to-treat-dermatomyositis-in-adults"
content_type: "clinical_feed_article"
specialty: "Rheumatology"
source_name: "FDA News Releases"
source_url: "http://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-drug-indicated-treat-dermatomyositis-adults"
published_at: "2026-08-27T19:11:11.000Z"
evidence_level: "Agency Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# FDA Approves Lisraya (brepocitinib) — First Oral Treatment for Adult Dermatomyositis
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/fda-news-releases-0-fda-approves-first-oral-drug-indicated-to-treat-dermatomyositis-in-adults
- **Specialty:** [Rheumatology](https://medichelpline.com/clinical-feed/rheumatology.md)
- **Primary Source:** FDA News Releases
- **Source URL:** [Original Journal Publication](http://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-drug-indicated-treat-dermatomyositis-adults)
- **Published At:** 2026-08-27T19:11:11.000Z
- **Evidence Rating:** Agency Feed
## Executive GIST (TL;DR)
- The FDA approved **Lisraya** (brepocitinib) tablets as the first FDA‑approved oral therapy indicated for adults with **dermatomyositis**, addressing a long‑standing unmet need for this rare autoimmune disease. - Lisraya is a once‑daily oral **JAK/TYK2 inhibitor** that reduces immune‑mediated inflammation affecting skin and muscle. - Approval was based on a phase 3, randomized, double‑blind, multicenter, placebo‑controlled trial (NCT05437263) that enrolled 241 adults with dermatomyositis and evaluated treatment over 52 weeks. - Participants were randomized to brepocitinib 30 mg once daily, brepocitinib 15 mg once daily, or placebo. - The primary efficacy measure included the **Total Improvement Score (TIS)** at week 52, a composite across six domains: muscle strength, physical function, skin and other disease activity, muscle enzymes, physician global assessment, and patient global assessment. - Lisraya 30 mg demonstrated a higher average TIS at week 52 versus placebo and showed improvements in physical function and skin disease activity; patients on the 30 mg dose were more likely to reduce corticosteroid use by week 48. - Common adverse reactions included upper respiratory tract infection, headache, fatigue, urinary tract infection, and nausea. - Discontinuations due to adverse reactions were 6% for Lisraya 30 mg versus 11% for placebo in the trial. - Lisraya carries a boxed warning for **serious infections**, increased **all‑cause mortality**, **malignancies**, **major adverse cardiovascular events**, and **thrombosis**. - The FDA granted Lisraya Orphan Drug and Priority Review designations. - The approval was granted to Priovant Therapeutics Inc. - The FDA statement emphasized that this approval provides an approved, evidence‑based oral option for clinicians and patients who previously relied on therapies intended for other conditions.
## Clinical Analysis & Structured Key Points
* [Skip to main content](https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-drug-indicated-treat-dermatomyositis-adults#main-content) * [Skip to FDA Search](https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-drug-indicated-treat-dermatomyositis-adults#search-form) * [Skip to in this section menu](https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-drug-indicated-treat-dermatomyositis-adults#section-nav) * [Skip to footer links](https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-drug-indicated-treat-dermatomyositis-adults#footer) ![U.S. flag](https://www.fda.gov/themes/custom/preview/assets/images/US_Flag.png) An official website of the United States government [Here’s how you know ](https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-drug-indicated-treat-dermatomyositis-adults) ![Dot gov](https://www.fda.gov/themes/custom/preview/assets/images/icon-dot-gov.svg) **The .gov means it’s official.** Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. ![SSL](https://www.fda.gov/themes/custom/preview/assets/images/icon-https.svg) **The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. ###### Recall Alert An update on the Cyclospora outbreak available [here](https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-5-state-outbreak-cyclospora-illnesses-iceberg-lettuce-july-2026). [ ![U.S. Food and Drug Administration logo](https://www.fda.gov/themes/custom/preview/assets/images/FDA_Logo_Icon_White.svg) ](https://www.fda.gov/ "FDA Homepage") * Search * Menu Search FDA Submit search ## Featured * [Report a Product Problem](https://contact.fda.gov/report-problem?utm_medium=referral&utm_source=fda_gov_menu "Report a Problem with an FDA Regulated Product") * [Contact FDA](https://www.fda.gov/about-fda/contact-fda) * [FDA Guidance Documents](https://www.fda.gov/regulatory-information/search-fda-guidance-documents) * [Recalls, Market Withdrawals and Safety Alerts](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts) * [Press Announcements](https://www.fda.gov/news-events/newsroom/press-announcements) * [Warning Letters](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters) * [Advisory Committees](https://www.fda.gov/advisory-committees) * [En Español](https://www.fda.gov/fda-en-espanol) ## Products * [Food](https://www.fda.gov/food) * [Drugs](https://www.fda.gov/drugs) * [Medical Devices](https://www.fda.gov/medical-devices) * [Radiation-Emitting Products](https://www.fda.gov/radiation-emitting-products) * [Vaccines, Blood, and Biologics](https://www.fda.gov/vaccines-blood-biologics) * [Animal and Veterinary](https://www.fda.gov/animal-veterinary) * [Cosmetics](https://www.fda.gov/cosmetics) * [Tobacco Products](https://www.fda.gov/tobacco-products) ## Topics * [About FDA](https://www.fda.gov/about-fda) * [Combination Products](https://www.fda.gov/combination-products) * [Regulatory Information](https://www.fda.gov/regulatory-information) * [Safety](https://www.fda.gov/safety) * [Emergency Preparedness](https://www.fda.gov/emergency-preparedness-and-response) * [International Programs](https://www.fda.gov/international-programs) * [News and Events](https://www.fda.gov/news-events) * [Training and Continuing Education](https://www.fda.gov/training-and-continuing-education) * [Inspections and Compliance](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations) * [Science and Research](https://www.fda.gov/science-research) ## Information For * [Consumers](https://www.fda.gov/consumers) * [Patients](https://www.fda.gov/patients) * [Industry](https://www.fda.gov/industry) * [Health Professionals](https://www.fda.gov/health-professionals) * [Federal, State and Local Officials](https://www.fda.gov/federal-state-local-tribal-and-territorial-officials) 1. [Home](https://www.fda.gov/) 2. [News & Events](https://www.fda.gov/news-events) 3. [FDA Newsroom](https://www.fda.gov/news-events/fda-newsroom) 4. [Press Announcements](https://www.fda.gov/news-events/fda-newsroom/press-announcements) 5. FDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults 1. [ Press Announcements ](https://www.fda.gov/news-events/fda-newsroom/press-announcements "Press Announcements") [In this section](https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-drug-indicated-treat-dermatomyositis-adults#section-nav) * [ Press Announcements ](https://www.fda.gov/news-events/fda-newsroom/press-announcements "Press Announcements") FDA News Release # FDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults Lisraya is the first FDA-approved oral treatment option for patients with dermatomyositis, addressing the high unmet need for this rare disease. [ More Press Announcements](https://www.fda.gov/news-events/newsroom/press-announcements) For Immediate Release: August 27, 2026 The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets for the treatment of dermatomyositis in adults. For decades, dermatomyositis patients have had limited treatment options to manage their symptoms. The approval of Lisraya offers patients an important new alternative by providing an effective oral treatment option. “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.” 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. Lisraya is a once-daily oral tablet that works as a Janus kinase (JAK/TYK2) inhibitor. By blocking JAK pathways, which play a key role in the body's immune and inflammatory responses, Lisraya helps reduce the harmful inflammation that damages the muscles and skin, offering an effective new option for disease control. The efficacy and safety of Lisraya were evaluated in a phase 3 randomized, double-blind, multicenter, placebo-controlled study ([NCT05437263](https://clinicaltrials.gov/study/NCT05437263)) that included 241 adults with dermatomyositis. Participants were randomized to receive Lisraya (brepocitinib) 30 mg once daily, brepocitinib 15 mg once daily or placebo for a 52-week treatment period. 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 TIS score (indicating greater clinical response and disease control) at week 52 compared to those who received a placebo. They also showed improvements in physical function and skin disease activity and were more likely to reduce corticosteroid use by week 48. Some of the most common adverse reactions to Lisraya were upper respiratory tract infection, headache, fatigue, urinary tract infection, and nausea. Discontinuation due to adverse reactions occurred in 6% of participants treated with Lisraya 30 mg, compared with 11% of those given a placebo. Lisraya carries a boxed warning for serious infections, increased all-cause mortality (a higher risk of death from any cause), malignancies (cancers), major adverse cardiovascular events (serious heart and blood vessel problems), and thrombosis (blood clots). The FDA granted Lisraya [Orphan Drug](https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products "Designating an Orphan Product: Drugs and Biological Products") and [Priority Review](https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review "Priority Review") designations. The approval of Lisraya for the treatment of dermatomyositis was granted to Priovant Therapeutics Inc. * * * **Media:** [FDA Request for Comment](https://www.hhs.gov/request-for-comment-form/index.html?Agency=FDA) 202-690-6343 **Consumer:** 888-INFO-FDA ### Boilerplate The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products. * * * * ## Content current as of: 08/27/2026 * ## Regulated Product(s) * Drugs * ## Follow FDA * [ Follow @US_FDA on X ](https://x.com/FDA)[External Link Disclaimer](http://www.fda.gov/about-fda/website-policies/website-disclaimer) * [Follow FDA on Facebook](https://www.facebook.com/FDA)[External Link Disclaimer](http://www.fda.gov/about-fda/website-policies/website-disclaimer) * [ Follow @FDAMedia on X ](https://x.com/FDAMedia)[External Link Disclaimer](http://www.fda.gov/about-fda/website-policies/website-disclaimer) # Feedback form ## Success Thank you. Your feedback has been received. ## Error alert message Was this page helpful? * Yes No Submit ![U.S. flag](https://touchpoints.app.cloud.gov/img/us_flag_small.png) An official form of the United States government. Provided by [Touchpoints](https://touchpoints.digital.gov) Feedback * [FDA Archive](https://www.fda.gov/about-fda/about-website/fdagov-archive) * [About FDA](https://www.fda.gov/about-fda) * [Accessibility](https://www.fda.gov/about-fda/about-website/internet-accessibility) * [Visitor Information](https://www.fda.gov/about-fda/visitor-information) * [Website Policies / Privacy](https://www.fda.gov/about-fda/about-website/website-policies) * [No FEAR Act](https://www.fda.gov/about-fda/jobs-and-training-fda/no-fear-act) * [Vulnerability Disclosure Policy](https://www.hhs.gov/vulnerability-disclosure-policy/index.html) * [FOIA](https://www.fda.gov/regulatory-information/freedom-information "Freedom of Information Act") * [HHS.gov](https://www.hhs.gov/ "Health and Human Services") * [USA.gov](https://www.usa.gov/) [Contact FDA](https://www.fda.gov/about-fda/contact-fda) [ Follow FDA on Facebook ](https://www.facebook.com/FDA "Follow FDA on Facebook") [ Follow FDA on X ](https://x.com/FDA "Follow FDA on X") [ Follow FDA on Instagram ](https://instagram.com/FDA "Follow FDA on Instagram") [ Follow FDA on LinkedIn ](https://www.linkedin.com/company/fda/ "Follow FDA on LinkedIn") [ View FDA videos on YouTube ](https://youtube.com/@US_FDA "View FDA videos on YouTube") [ Subscribe to FDA RSS feeds ](https://www.fda.gov/about-fda/contact-fda/subscribe-podcasts-and-news-feeds "Subscribe to FDA RSS feeds") [ ![Food and Drug Administration Logo](https://www.fda.gov/themes/custom/preview/assets/images/FDA_Logo_Icon_White.svg) ](https://www.fda.gov/ "FDA Homepage") Contact Number 1-888-INFO-FDA (1-888-463-6332) [Back to Top](https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-drug-indicated-treat-dermatomyositis-adults) *[*]: required
## Related Clinical Research

- [Single-cell genomics in rheumatoid arthritis: from synovial niches to new therapies](https://medichelpline.com/clinical-feed/nature-immunology-2-immune-mediated-rheumatoid-arthritis-from-single-cell-genomics-to-new-therapies.md)
- [Synovial Immune Control Failure in Osteoarthritis: From Homeostasis to Inflammatory Niche Formation](https://medichelpline.com/clinical-feed/frontiers-in-immunology-14-synovial-immune-control-failure-in-osteoarthritis-from-maintenance-of-tissue.md)
- [Phycocyanobilin from Arthrospira platensis as a candidate LYN kinase modulator in systemic lupus e](https://medichelpline.com/clinical-feed/plos-one-15-phycocyanobilin-a-potential-bioactive-compound-from-arthrospira-platensis.md)
- [Acetylation-related biomarkers in osteoarthritis: bioinformatics identification of JUN and MYC](https://medichelpline.com/clinical-feed/plos-one-5-exploration-of-acetylation-related-biomarkers-in-osteoarthritis-through.md)
- [Effectiveness and Safety of Tocilizumab in Refractory Rheumatoid Arthritis: A Moroccan Study](https://medichelpline.com/clinical-feed/medrxiv-12-real-world-effectiveness-and-safety-of-tocilizumab-in-refractory-rheumatoid.md)

## Navigation
- [← Back to Rheumatology Feed](https://medichelpline.com/clinical-feed/rheumatology.md)
- [← All Clinical Specialties](https://medichelpline.com/clinical-feed.md)
## Medical & Regulatory Disclaimer

> [!CAUTION]
> MedicHelpline content is structured for research, educational, and professional discovery purposes. It does not constitute individual medical advice, clinical diagnosis, or treatment recommendations.
> Always verify dosing, contraindications, and regulatory alerts against official product labeling and primary regulatory sources before clinical decision-making.