Brodalumab

Overview

Brodalumab has been used in trials studying the treatment of Asthma, Psoriasis, Crohn's Disease, Psoriatic Arthritis, and Rheumatoid Arthritis. Brodalumab was FDA approved in February, 2017 as Siliq for the treatment of moderate-to-severe plaque psoriasis.

Indication

Brodalumab has been approved for the treatment of psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma.

Associated Conditions

Severe Plaque psoriasis
Moderate Plaque psoriasis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Brodalumab in the Treatment of Immune-Related Adverse Events	2024/11/04	NCT06673329	Phase 1	Recruiting	Brian Henick, MD
Canadian Real World Evidence Study of Brodalumab in Plaque Psoriasis to Understand the Impact on Quality of Life and Work Productivity	2021/11/24	NCT05132231	N/A	Active, not recruiting	Bausch Health Americas, Inc.
Molecular Characteristics of Brodalumab in Hidradenitis Suppurativa	2021/07/28	NCT04979520	Early Phase 1	Completed	Rockefeller University
Efficacy and Safety of Brodalumab Compared With Guselkumab in the Treatment of Plaque Psoriasis After Inadequate Response to Ustekinumab	2020/09/01	NCT04533737	Phase 4	Terminated	LEO Pharma
A Study of KHK4827 in Patients With Systemic Sclerosis	2020/04/29	NCT04368403	Phase 1	Completed	Kyowa Kirin Co., Ltd.
Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis	2020/04/09	NCT04340076	Phase 4	Active, not recruiting	Radboud University Medical Center
Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis	2020/03/12	NCT04305327	Phase 3	Terminated	LEO Pharma
Adjusted Brodalumab Dose Compared With Standard Brodalumab Dose in Subjects With Moderate-to-severe Plaque Psoriasis and ≥120 kg Body Weight	2020/03/12	NCT04306315	Phase 4	Active, not recruiting	LEO Pharma
An Alternative Dose Interval Study in Participants With Hidradenitis Suppurativa Receiving Brodalumab	2020/01/31	NCT04249713	Early Phase 1	Withdrawn	Rockefeller University
A Phase 4 Clinical Study of Brodalumab	2019/12/03	NCT04183881	Phase 4	Completed	Kyowa Kirin Co., Ltd.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Siliq	Bausch Health US LLC	0187-0004	SUBCUTANEOUS	210 mg in 1 1	9/1/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Kyntheum	LEO Pharma A/S,Industriparken 55,DK-2750 Ballerup,Denmark	Authorised	7/17/2017

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Brodalumab Injection	KYOWA KIRIN CO., LTD.	S20200018	生物制品	注射剂	6/17/2020

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
LUMICEF SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 210MG/1.5ML	N/A	DKSH Hong Kong Limited	N/A	N/A	2/27/2019

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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