Roivant’s brepocitinib beats placebo in Phase 3 dermatomyositis trial, NEJM reports

Reuters03:00

Roivant’s brepocitinib beats placebo in Phase 3 dermatomyositis trial, NEJM reports

Roivant reported New England Journal of Medicine publication of Phase 3 VALOR results for brepocitinib in adults with dermatomyositis.
Trial met primary endpoint, with brepocitinib 30 mg once daily delivering 15.3-point greater improvement in mean Total Improvement Score at Week 52 versus placebo (P<0.001).
Data showed clinically meaningful steroid-sparing effect, with nearly twice as many patients reducing background corticosteroids in brepocitinib 30 mg group versus placebo.
Safety profile showed higher serious infection rate with brepocitinib 30 mg versus placebo, while discontinuations were more frequent on placebo.
Additional VALOR analyses were already presented at 2026 American Academy of Dermatology meeting; FDA granted Priority Review with PDUFA target action date in Q3 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Roivant Sciences Ltd. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202603281500PRIMZONEFULLFEED9680293) on March 28, 2026, and is solely responsible for the information contained therein.

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