Database for
Therapeutic Antibodies
Therapeutic Antibodies
| 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 |
| 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 | Cancer |
| 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 | Multicentric Castleman’s disease |
| 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 |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |