Is Icotrokinra approved by the US FDA?

Drugs@FDA lists 1 application product line for Icotrokinra, including ICOTYDE (Prescription).

Is Icotrokinra authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Icotrokinra: Icotyde.

Active substance

Icotrokinra

US FDA 1
EMA 1

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ICOTYDE	EQ 200MG BASE	tablet · oral	JANSSEN BIOTECH	Prescription	17 Mar 2026

EMA European Union — centrally authorised medicines

Icotyde Janssen-Cilag International · Authorised · authorised 18 Sep 2026 · ATC L04AC28

Therapeutic indication (EMA)

Icotyde is indicated for the treatment of moderate to severe plaque psoriasis in adults, and adolescents 12 years of age and older and weighing at least 40 kg, who are candidates for systemic therapy

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.