Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 119 |
| INN | Casirivimab, imdevimab |
| Status | Approved |
| Drug code(s) | REGEN-COV2 |
| Brand name | Ronapreve™ |
| mAb sequence source | mAb human |
| General Molecular Category | Mixture of 2 |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa, lambda |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | SARS-CoV-2 (spike protein) |
| Indications of clinical studies | COVID-19 |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Approved EU, Japan, Australia |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | June 11, 2020 |
| Start of Phase 2 | |
| Start of Phase 3 | June 30, 2020 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | 2021 |
| Date of first US approval | |
| INN, US product name | Casirivimab + imdevimab |
| US or EU approved indications | Treatment of COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of their disease becoming severe. The medicine can also be used to prevent COVID-19 in people aged 12 years and older weighing at least 40 kilograms. |
| Company | Regeneron Pharmaceuticals |
| Licensee/Partner | None |
| Comments about company or candidate | Approved under emergency provisions in Japan; Emerency use authorization in Canada, India, Switzerland PDUFA date is April 13, 2022; Emerency use authorization granted but withdrawn in US; Sep 20 201 press release – First of 2 BLAs was submitted in Aug 2021 Japan’s Ministry of Health, Labour and Welfare (MHLW) approved Ronapreve™(casirivimab and imdevimab) on July 21, 2021, for the treatment of patients with mild to moderate COVID-19 via intravenous infusion. The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. On June 11, 2020, Regeneron Pharmaceuticals, Inc. announced the start of the first clinical trial of REGN-COV2 for the prevention and treatment of COVID-19. REGN-COV2 is a cocktail of the human antibodies REGN10933 and REGN10987, which were derived from Regeneron’s parallel efforts using both humanized VelocImmune® mice and blood samples from recovered COVID-19 patients to generate a large and diverse collection of antibodies targeting multiple different regions of the receptor-binding domain of the SARS-CoV-2 spike protein. Two papers describing the creation of REGN-COV2 and its anti-viral activity have been accepted for publication in Science. The REGN-COV2 clinical program will consist of four separate study populations: hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, uninfected people in groups that are at high-risk of exposure and uninfected people with close exposure to a COVID-19 patient. The placebo-controlled trials will be conducted at multiple sites. The first two adaptive Phase 1/2/3 studies are evaluating REGN-COV2 as a treatment for hospitalized and non-hospitalized patients with COVID-19. The Phase 1 portion will focus on virologic and safety endpoints, and the Phase 2 portion will focus on virologic and clinical endpoints. Data from the Phase 1 and Phase 2 studies will be used to refine the endpoints and determine size for the Phase 3 studies. |
| Full address of company | Tarrytown, New York, United States North America United States of America https://www.regeneron.com/ |
REGN10933 + REGN10987. Imdevimab is IgG1 lambda; casirivimab is IgG1 kappa INN were formerly nepuvibart and masavibart
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |