Treats moderate-to-severe plaque psoriasis. NDA 220149, held by Janssen Biotech. Icotrokinra Hydrochloride.
As of Nov 13, 2026, NDA 220149 (Icotyde), held by Janssen Biotech, was first approved by FDA on Mar 17, 2026, with 0 approved supplements and 0 published complete response letters.
ICOTYDE is indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 17, 2026 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| IcotydeEQ 200MG BASE · tablet;oral | Icotrokinra Hydrochloride | 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
