FDA Approves Lisraya as First Oral Treatment for Adults With Dermatomyositis
The U.S. Food and Drug Administration (FDA) has approved Lisraya (brepocitinib) as the first FDA-approved oral treatment specifically indicated for adults with dermatomyositis, a rare autoimmune condition that can affect both the muscles and skin.
The FDA announced the approval on August 27, 2026, describing Lisraya as an important new treatment option for people living with the debilitating disease. The medication is manufactured by Priovant Therapeutics and is taken once daily.
The decision is particularly significant because people with dermatomyositis have historically had limited treatment options specifically approved for the condition. Dermatomyositis can cause progressive muscle weakness, inflammation and characteristic skin rashes, potentially affecting physical function and quality of life.
What Is Dermatomyositis?
Dermatomyositis is a rare immune-mediated disease in which the body's immune system mistakenly attacks healthy tissues, particularly the muscles and skin.
People with the condition may experience muscle weakness, inflammation and skin changes. Muscle weakness can interfere with everyday activities, while skin symptoms may include painful or itchy lesions and distinctive rashes.
Because dermatomyositis can involve several aspects of a person's health, treatment may focus on controlling inflammation, improving muscle function, managing skin symptoms and reducing the need for corticosteroids.
The FDA says Lisraya offers a new oral approach to managing the disease by targeting immune pathways involved in inflammation.
FDA Approval Supported by Phase 3 Clinical Trial
The approval of Lisraya was supported by results from a phase 3 clinical trial known as VALOR. The randomized, double-blind, multicenter, placebo-controlled study enrolled 241 adults with dermatomyositis.
Participants were assigned to receive either Lisraya at 30 mg once daily, Lisraya at 15 mg once daily or placebo. Researchers followed participants over a 52-week treatment period.
One of the primary measures used in the study was the Total Improvement Score, or TIS. This standardized measurement considers multiple areas of dermatomyositis, including muscle strength, physical function, skin and other disease activity, muscle enzyme levels, and assessments made by both doctors and patients.
At week 52, participants receiving the 30 mg dose of Lisraya had a higher average TIS than those receiving placebo. According to the FDA, the results indicated greater overall clinical improvement and disease control among patients receiving the higher dose.
Improvements in Muscle, Physical Function and Skin Symptoms
The benefits observed in the trial extended beyond the overall improvement score.
Patients treated with Lisraya experienced improvements in physical function and skin disease activity. These findings are important because dermatomyositis can affect both a person's ability to perform everyday activities and their skin health.
The trial also found that people taking Lisraya were more likely to reduce their corticosteroid use by week 48.
Corticosteroids are commonly used to control inflammation in autoimmune diseases, but long-term use can be associated with significant side effects. A treatment that may allow some patients to reduce corticosteroid exposure could therefore represent an important consideration in long-term disease management.
However, whether a person can reduce or stop corticosteroids depends on their individual disease activity and treatment plan. Patients should never change their corticosteroid dose without guidance from their healthcare professional.
How Does Lisraya Work?
Lisraya contains the active ingredient brepocitinib. It is a once-daily oral medication that inhibits Janus kinase 1, or JAK1, and tyrosine kinase 2, known as TYK2.
These pathways are involved in signaling processes that regulate immune and inflammatory responses. By interfering with these pathways, brepocitinib is intended to reduce abnormal immune activity associated with dermatomyositis.
This mechanism gives patients an oral treatment designed to directly target important immune signaling pathways involved in the disease.
Common Side Effects Reported in the Trial
Like other prescription medicines, Lisraya can cause side effects.
The FDA reported that some of the most common adverse reactions observed with Lisraya included:
- Upper respiratory tract infections
- Headache
- Fatigue
- Urinary tract infections
- Nausea
In the phase 3 study, adverse reactions resulted in treatment discontinuation for 6% of participants receiving Lisraya 30 mg, compared with 11% of participants receiving placebo.
The FDA also notes that Lisraya carries a boxed warning concerning potentially serious risks, including serious infections, increased risk of death from any cause, malignancies, major cardiovascular events and thrombosis, or blood clots.
Because of these risks, treatment decisions should be made with a qualified healthcare professional who can consider a patient's medical history, other medications and individual risk factors.
Why the Approval Matters
The FDA's decision marks an important development in the treatment of dermatomyositis.
The condition is rare and can be difficult to manage because it may affect multiple areas of the body. Before this approval, patients often relied on medications and treatment approaches that were not specifically approved by the FDA for dermatomyositis.
The availability of an oral treatment provides another option for patients and healthcare professionals.
The FDA described the approval as a meaningful step for people living with the disease, particularly given the long-standing need for effective treatment options.
Lisraya also received Orphan Drug and Priority Review designations from the FDA during its development and review process. The drug's approval for adults with dermatomyositis was granted to Priovant Therapeutics Inc.
What Patients Should Know
FDA approval does not mean that Lisraya will be appropriate for every person with dermatomyositis.
Doctors may consider several factors before prescribing the medication, including the severity of the disease, current symptoms, previous treatments, other medical conditions and potential medication interactions.
Patients should also discuss the risks associated with JAK and TYK2 inhibition with their healthcare provider. The FDA's boxed warning highlights several potentially serious complications, making individualized medical supervision particularly important.
The approval does, however, provide another treatment option for adults with dermatomyositis and represents a notable development in the management of this rare autoimmune disease.
The Bottom Line
Lisraya (brepocitinib) has been approved by the FDA as the first oral treatment indicated for adults with dermatomyositis. The approval was supported by a phase 3 study involving 241 adults, in which the 30 mg once-daily dose produced greater improvement in the Total Improvement Score compared with placebo after 52 weeks.
The treatment was also associated with improvements in physical function and skin disease activity, as well as a greater likelihood of corticosteroid reduction.
While the approval offers a new option for adults living with dermatomyositis, Lisraya also carries important safety warnings. Patients should discuss its potential benefits and risks with their healthcare provider before starting treatment.
Source
- U.S. Food and Drug Administration. "FDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults." August 27, 2026.
Medical Disclaimer
This article is provided for informational and educational purposes only. It is not intended to provide medical advice, diagnosis or treatment recommendations. Information about medications, clinical trials, benefits and risks may change as additional evidence becomes available. Individual responses to treatment can vary. Always consult a qualified healthcare professional before starting, stopping or changing any medication or treatment. Do not use this article as a substitute for advice from your doctor or other licensed medical professional.