The US FDA has approved Priovant Therapeutics’ Lisraya (brepocitinib) tablets 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.

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.

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.

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 randomised, double-blind, multicentre, placebo-controlled study that included 241 adults with dermatomyositis. Participants were randomised to receive Lisraya 30mg once daily, brepocitinib 15mg once daily or placebo for a 52-week treatment period.

The study measured Total Improvement Score (TIS) at week 52, a standardised 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 30mg 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.

“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, Director of the Office of Immunology and Inflammation at the FDA’s Center for Drug Evaluation and Research. “This 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.”

Galderma has shared new three-year data from the ARCADIA long-term extension study, demonstrating that Nemluvio is well tolerated and associated with sustained and continuous improvements in skin lesions, itch, sleep disturbance and quality of life in adults and adolescents with moderate-to-severe atopic dermatitis.

The study assesses the long-term safety and efficacy of Nemluvio in adults and adolescents aged ≥12 years with moderate-to-severe atopic dermatitis for up to 200 weeks. Additional analyses further establish itch and skin lesions as central drivers of sleep disturbance and overall quality of life impairment in prurigo nodularis and atopic dermatitis.

The findings, shared at EADV 2026, show that up to 91% of patients achieved at least 75% improvement in eczema severity, up to 67% achieved near-complete skin clearance, and approximately 90% reported clinically meaningful improvements in itch and quality of life at Week 152.

Nemluvio is the first approved monoclonal antibody that specifically targets and inhibits the signalling of IL-31 – a neuroimmune cytokine that drives itch and is involved in inflammation and epidermal dysregulation in both atopic dermatitis and prurigo nodularis and in fibrosis in prurigo nodularis.