The Front Room — a clinical regulatory commons
RSS
← Back to The Docket
AUG 27 2026
APPROVED · 33 DAYS AGO

Priovant Therapeutics — Lisraya (brepocitinib)

for dermatomyositis

NDA · Priority Review

About

Dermatomyositis is a long-term autoimmune disorder in which the immune system attacks the skin and muscles, causing rashes and worsening muscle weakness that can develop suddenly or over months. Lisraya (brepocitinib) is a pill that blocks two proteins inside immune cells, TYK2 and JAK1, that carry the signals driving that attack. By interrupting these signals, brepocitinib may calm the immune response and could help reduce muscle weakness and skin symptoms in people with this condition.

Pivotal trial

VALOR Phase 3 completed NCT05437263

This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (TYK2/JAK1 inhibitor) in adults with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of two dose levels of brepocitinib in comparison to placebo, as measured by differences in the Total Improvement Score (TIS)

Source: ClinicalTrials.gov

Also in development