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SEP 3 2026
UPCOMING · 92 DAYS TO PDUFA

Priovant Therapeutics brepocitinib

for dermatomyositis

NDA · Priority Review

About

Dermatomyositis is a chronic autoimmune disease that causes skin rashes and progressive muscle weakness, often accompanied by fever, lung inflammation, or sensitivity to light. Brepocitinib blocks two immune system signals (TYK2 and JAK1) that drive inflammation and tissue damage. By quieting these pathways, the drug may reduce both the skin and muscle symptoms that disrupt daily life for people with this condition.

Pivotal trial

VALOR Phase 3 active not recruiting 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