Siltuximab Approved Naked monospecific

Antibody Information

Entry ID	54
INN	Siltuximab
Status	Approved
Drug code(s)	CNTO-328, cCLB8, CLB IL6/8
Brand name	Sylvant
mAb sequence source	mAb chimeric
General Molecular Category	Naked monospecific
Format, general category	Full length Ab
Format details	None
Isotype (Fc)	IgG1
Light chain isotype	kappa
Linker	None
Ave. DAR	None
Conjugated/fused moiety	None
Discovery method/technology	None

Therapeutic information

Target(s)	IL-6
Indications of clinical studies	COVID-19, Multiple Myeloma, Multicentric Castleman's Disease, Ovarian Neoplasms; Pancreatic Neoplasms; Colorectal Neoplasms; Head and Neck Neoplasms; Lung Neoplasms, Prostate cancer, Renal cell carcinoma, Myelodysplastic Syndrome
Primary therapeutic area	Immune-mediated / inflammatory disorders

Development stage information

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

Most advanced stage of development (global)	Approved EU, US, Australia
Status	Active
Start of clinical phase (IND filing or first Phase 1)	July 01, 1995
Start of Phase 2
Start of Phase 3
Date BLA/NDA submitted to FDA	August 30, 2013
Year of first approval (global)	2014
Date of first US approval	April 23, 2014
INN, US product name	Siltuximab
US or EU approved indications	US: First approval for Multicentric Castleman’s disease (SYLVANT is indicated for the treatment of patients with multicentric Castleman’s disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) negative.) (as of first label and December 5, 2019 label).

Company information

Company	Janssen Research & Development
Licensee/Partner	EUSA Pharma, BeiGene
Comments about company or candidate	Jan. 13, 2020: EUSA Pharma (EUSA) and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) today announced that they have entered into an exclusive development and commercialization agreement for the orphan biologic products SYLVANT® (siltuximab) and QARZIBA®▼ (dinutuximab beta) in Greater China. July 2018: EUSA Pharma (EUSA), a biopharmaceutical company focused on oncology and rare disease, announced today that it has entered into a definitive agreement with Janssen Sciences Ireland UC, a subsidiary of Janssen R&D Ireland (Janssen) to acquire the global rights to SYLVANT® (siltuximab) for $115 million in cash. CHMP positive opinion given March 20, 2014; approval expected ~June 1. Marketing applications submitted in the EU and US for multicentric Castleman's disease on ~9/3/2013; priority review granted. First approval in US for multicentric Castleman's disease
Full address of company	1125 Trenton-Harbourton Road Titusville, NJ 08560 North America United States of America https://www.janssen.com/us/contact-us

Description/comment

None

Additional information

Anticipated events	None
Factor(s) contributing to discontinuation	None