imdevimab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
primate origin	5456	2415933-40-1

Description:

Molecule	Description
Molfile Synonyms: imdevimab REGN10987	Imdevimab with casirivimab to be administered together is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. Casirivimab(IgG1kappa) and imdevimab (IgG1lambda) are two recombinant human mAbs which are unmodified in the Fc regions. Casirivimab and imdevimab bind to non-overlapping epitopes of the spike protein receptor binding domain (RBD) of SARS-CoV-2. Casirivimab, imdevimab and casirivimab and imdevimab together blocked RBD binding to the human ACE2 receptor with IC50 values of 56.4 pM, 165 pM and 81.8 pM, respectively. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Molfile

Synonyms:

imdevimab
REGN10987

Imdevimab with casirivimab to be administered together is authorized for use under an EUA for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. Casirivimab(IgG1kappa) and imdevimab (IgG1lambda) are two recombinant human mAbs which are unmodified in the Fc regions. Casirivimab and imdevimab bind to non-overlapping epitopes of the spike protein receptor binding domain (RBD) of SARS-CoV-2. Casirivimab, imdevimab and casirivimab and imdevimab together blocked RBD binding to the human ACE2 receptor with IC50 values of 56.4 pM, 165 pM and 81.8 pM, respectively.

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

Date	Agency	Company
Nov. 12, 2021	EMA	ROCHE REGISTRATION GMBH
Nov. 21, 2020	FDA	Regeneron Pharmaceuticals, Inc.
July 19, 2021	PMDA	CHUGAI PHARMACEUTICAL Co., Ltd

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Infusion related reaction	115.44	47.45	53	569	245468	63242932
COVID-19 pneumonia	79.81	47.45	20	602	14189	63474211
Flushing	64.36	47.45	25	597	75062	63413338

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Infusion related reaction	129.23	49.69	43	504	53014	34903370
COVID-19 pneumonia	71.45	49.69	21	526	16946	34939438
Hypoxia	50.54	49.69	22	525	55073	34901311

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Infusion related reaction	228.99	52.80	97	1159	230140	79512992
COVID-19 pneumonia	149.26	52.80	42	1214	28807	79714325
Hypoxia	83.91	52.80	38	1218	103205	79639927
Dyspnoea	83.23	52.80	83	1173	856942	78886190
Oxygen saturation decreased	67.08	52.80	35	1221	129012	79614120
Flushing	63.87	52.80	30	1226	88238	79654894

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	J06BD07	ANTIINFECTIVES FOR SYSTEMIC USE IMMUNE SERA AND IMMUNOGLOBULINS IMMUNOGLOBULINS Antiviral monoclonal antibodies

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
COVID-19	indication	840539006

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Spike glycoprotein	Glycoprotein		SPIKE_SARS2	BINDING AGENT	Kd	10.33		DRUG LABEL	DRUG LABEL

External reference:

ID	Source
D11939	KEGG_DRUG
2Z3DQD2JHM	UNII
C5422689	UMLSCUI
CHEMBL4650249	ChEMBL_ID
DB15940	DRUGBANK_ID
11863	INN_ID
11328	IUPHAR_LIGAND_ID
018564	NDDF
1137367000	SNOMEDCT_US
1162695009	SNOMEDCT_US
4039879	VANDF
2465249	RXNORM
341255	MMSL
39042	MMSL
d09685	MMSL
C000711488	MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Imdevimab	HUMAN PRESCRIPTION DRUG LABEL	1	61755-025	INJECTION, SOLUTION, CONCENTRATE	1332 mg	INTRAVENOUS	UNAPPROVED DRUG OTHER	32 sections
Imdevimab	HUMAN PRESCRIPTION DRUG LABEL	1	61755-025	INJECTION, SOLUTION, CONCENTRATE	1332 mg	INTRAVENOUS	UNAPPROVED DRUG OTHER	32 sections
Imdevimab	HUMAN PRESCRIPTION DRUG LABEL	1	61755-027	INJECTION, SOLUTION, CONCENTRATE	300 mg	INTRAVENOUS	UNAPPROVED DRUG OTHER	32 sections
Imdevimab	HUMAN PRESCRIPTION DRUG LABEL	1	61755-027	INJECTION, SOLUTION, CONCENTRATE	300 mg	INTRAVENOUS	UNAPPROVED DRUG OTHER	32 sections
REGEN-COV	HUMAN PRESCRIPTION DRUG LABEL	2	61755-039	INJECTION, SOLUTION, CONCENTRATE	600 mg	INTRAVENOUS	UNAPPROVED DRUG OTHER	32 sections
REGEN-COV	HUMAN PRESCRIPTION DRUG LABEL	2	61755-039	INJECTION, SOLUTION, CONCENTRATE	600 mg	INTRAVENOUS	UNAPPROVED DRUG OTHER	32 sections