Treats dermatomyositis. NDA 220106, held by Priovant Therap. Brepocitinib Tosylate.
As of Nov 14, 2026, NDA 220106 (Lisraya), held by Priovant Therap, was first approved by FDA on Aug 27, 2026, with 0 approved supplements and 0 published complete response letters.
LISRAYA is indicated for the treatment of dermatomyositis in adult patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 27, 2026 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| LisrayaEQ 30MG BASE · tablet;oral | Brepocitinib Tosylate | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
