Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 123 |
| INN | Dupilumab |
| Status | Approved |
| Drug code(s) | REGN668, SAR231893 |
| Brand name | Dupixent |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic mouse (Velocimmune) |
| Target(s) | IL-4R alpha |
| Indications of clinical studies | Nasal Polyps, atopic dermatitis, Asthma |
| Primary therapeutic area | Immune-mediated / inflammatory disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan, Australia, UK |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | September 15, 2009 |
| Start of Phase 2 | March 15, 2011 |
| Start of Phase 3 | February 15, 2014 |
| Date BLA/NDA submitted to FDA | July 29, 2016 |
| Year of first approval (global) | 2017 |
| Date of first US approval | March 28, 2017 |
| INN, US product name | Dupilumab |
| US or EU approved indications | Atopic dermatitis; oral corticosteroid-dependent asthma; add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma; treatment of patients ages 12 to 17 with moderate-to-severe atopic dermatitis who have failed to respond adequately to topical therapies. In May 2019, Dupixent was approved in the European Union (EU) for use in adults and adolescents 12 years and older as an add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised fractional exhaled nitric oxide (FeNO), who are inadequately controlled with high dose inhaled corticosteroid (ICS) plus another medicinal product for maintenance treatment. June 2019: US approval for treatment of adults with nasal polyps accompanied by chronic rhinosinusitis. August 2019:EU approval for use in adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. In September 2022, the FDA approved Dupixent for the treatment of adult patients with prurigo nodularis |
| Company | Regeneron Pharmaceuticals |
| Licensee/Partner | Sanofi |
| Comments about company or candidate | March 2018: supplemental BLA submitted for drug as an add-on maintenance therapy for asthma. Approved March 28, 2017 in US; approved in EU (Sep 27, 2017) Aug 4 2016: Announced BLA recently submitted; expect approval in March 15-April 4 2017 range. Received breakthrough-therapy status from the FDA for use in patients with moderate to severe atopic dermatitis who are insufficiently responsive to or can't use topical prescription treatments in Nov 2014. Sanofi and Regeneron Pharmaceuticals announced positive Phase 2a study results of dupilumab (SAR231893/REGN668) in patients with moderate-to-severe allergic asthma in May 2013. Phase 3 NCT01949311 study in atopic dermatitis started in Feb 2014. Phase 3 in asthma started in April 2015. |
| Full address of company | Tarrytown, New York, United States North America United States of America https://www.regeneron.com/ |
Blocks interleukin-4 and interleukin-13 from binding the receptor, S233P hinge stabilization
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |