Roivant's Brepocitinib Clears Skin in Phase 3, Targeting 2026 FDA Approval

Priovant Therapeutics, a Roivant Sciences subsidiary, published skin-specific Phase 3 VALOR trial results for brepocitinib in JAMA Dermatology. The study evaluated the oral TYK2/JAK1 inhibitor in patients suffering from the autoimmune disease dermatomyositis.

Nearly half of patients receiving the 30 mg dose achieved clear or almost clear skin by week 52. This clinical success rate more than doubled the results observed in the placebo group.

Significant relief from itching occurred as early as four weeks into the treatment. The therapy enabled many participants to substantially reduce or entirely discontinue the use of oral corticosteroids.

The U.S. FDA is currently conducting a Priority Review for brepocitinib. The agency established a target action date for the third quarter of 2026.