Evinacumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2021
- First approval year
- 2021
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Evinacumab
- evkeeza
- Evkeeza
- evinacumab
- Evinacumab
- evinacumab [INN]
- EVINACUMAB [JAN]
- Evinacumab [MI]
- EVINACUMAB [USAN]
- Evinacumab [WHO-DD]
- evinacumab dgnb
- Evinacumab dgnb
- Evinacumab dgnb [WHO-DD]
- evinacumab dgnb who dd
- evinacumab inn
- evinacumab jan
- evinacumab mi
- evinacumab usan
- evinacumab who dd
- Evinacumab-dgnb
- immunoglobulin g4 anti human protein angptl3 angiopoietin like 3 human monoclonal regn1500 heavy chain disulfide with human monoclonal regn1500 light chain dimer
- IMMUNOGLOBULIN G4, ANTI-(HUMAN PROTEIN ANGPTL3 (ANGIOPOIETIN-LIKE 3)) (HUMAN MONOCLONAL REGN1500 HEAVY CHAIN), DISULFIDE WITH HUMAN MONOCLONAL REGN1500 LIGHT CHAIN, DIMER
- regn 1500
- REGN-1500
- regn1500
- REGN1500
- CAS registry numbers
- 1446419-85-7
- ChEMBL ID
- CHEMBL3545191
- FDA ingredient codes (UNII)
- T8B2ORP1DW
- C10AX
- C10AX17
Sources for recorded values
- 2478335
- 2478646
- Applicant
- REGENERON PHARMACEUTICALS
- Approval date
- 11 Feb 2021
- Application number
- BLA761181
- Status
- Authorised
- Status date
- 17 Jun 2021
- Authorisation date
- 17 Jun 2021
- Approved indications
- Evkeeza is indicated as an adjunct to diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and adolescent patients aged 12 years and older with homozygous familial hypercholesterolaemia (HoFH).
- Product number
- EMEA/H/C/005449
- Authorisation holder
- Ultragenyx Germany GmbH
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- Yes
Therapeutic areas
- Hypercholesterolemia
European medicines record
- Patents
- 0
- Designations
- 6
- Earliest recorded loss of exclusivity
- 21 Mar 2030
- First in class
- Yes
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- evinacumab
- Type
- Antibody
- Drug name stem
- -mab; -vin-
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Binding
- Action type
- Binding
- Target
- angiopoietin-like 3
- Gene symbol
- angiopoietin-like 3
- Median affinity
- 8.87
- Affinity units
- pKd
- Primary target
- Yes
- Mechanism
- Angiopoietin-related protein 3 inhibitor
- Action type
- Inhibitor
- Target
- Angiopoietin-related protein 3
- Protein identifier
- Q9Y5C1
Open Targets mechanisms
- Mechanism
- Angiopoietin-related protein 3 inhibitor
- Action type
- Inhibitor
- Target
- Angiopoietin-related protein 3
- Condition
- Cardiovascular Diseases
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000319
- Subject identifier
- D002318
- Condition
- Metabolic Diseases
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000589
- Subject identifier
- D008659
- Condition
- Hypertriglyceridemia
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004211
- Subject identifier
- D015228
- Condition
- Hyperlipoproteinemia Type II
- Highest recorded phase
- 4
- Condition identifier
- EFO:0004911
- Subject identifier
- D006938
- Condition
- Hypercholesterolemia
- Highest recorded phase
- 4
- Condition identifier
- HP:0003124
- Subject identifier
- D006937
- Condition
- Hyperlipoproteinemia Type II
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0018328
- Subject identifier
- D006938
- Condition identifier
- EFO_0000319
- Condition identifier
- EFO_0000589
- Highest recorded phase
- 1
- Condition identifier
- EFO_0004211
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004911
- Condition identifier
- HP_0003124
- Condition identifier
- HP_0003124
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0004995
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005016
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005347
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005439
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0006515
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0018328
- Condition identifier
- MONDO_0018328
- Highest recorded phase
- 4
Reported adverse events
- Event
- peripheral arterial occlusive disease
- Reports
- 2
- Reporting signal score
- 11.3677
- NCT01749878
- NCT03452228
- NCT04863014
- NCT02107872
- NCT02265952
- NCT03399786
- NCT03409744
- NCT04233918
- NCT05611528
- NCT03175367
- Dose
- 15 mg/kg
- Route
- Intravenous
- How often
- Once monthly
- Administer over 60 minutes
- Discard unused portion
- Do not freeze
- Do not mix with other medications or administer concomitantly via same line
- Store refrigerated at 2-8°C for no more than 24 hours or at room temperature up to 6 hours if not administered immediately
- Use sterile, in-line or add-on filter 0.2-5 microns
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Sequence
- EVQLVESGGGVIQPGGSLRLSCAASGFTFDDYAMNWVRQGPGKGLEWVSAISGDGGSTYYADSVKGRFTISRDNSKNSLYLQMNSLRAEDTAFFYCAKDLRNTIFGVVIPDAFDIWGQGTMVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPEFLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK
- Component
- Light chain
- Type
- Protein
- Sequence
- DIQMTQSPSTLSASVGDRVTITCRASQSIRSWLAWYQQKPGKAPKLLIYKASSLESGVPSRFSGSGSGTEFTLTISSLQPDDFATYYCQQYNSYSYTFGQGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
Related records
Trials (13)
- Compassionate Use of Evinacumab
- Efficacy and Safety of Evinacumab in Adult Patients With Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis
- Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
- Evaluate the Efficacy and Safety of Evinacumab in Pediatric Patients With Homozygous Familial Hypercholesterolemia
- Evaluate the Long-Term Safety and Efficacy of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia
- Safety and Effectiveness of Evinacumab for the Treatment of Homozygous Familial Hypercholesterolemia
- Safety and Efficacy Following Repeat-Dose of Evinacumab (Anti-ANGPTL3) in Patients With Severe Hypertriglyceridemia (sHTG) at Risk for Acute Pancreatitis
- Study of Evinacumab (REGN1500) in Caucasian and in Japanese Healthy Volunteers
- Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia
- Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
- Study to Assess the Effects of Angiopoietin-like Protein 3 (ANGPTL3) Inhibition in Adult Participants With Diabetic Kidney Disease
- Study to Assess the Safety and Tolerability of Multiple Ascending Doses of REGN1500
- Study to Assess the Safety and Tolerability of Single Doses of REGN1500
Approved for (3)
- Cardiovascular disorder
- Familial hypercholesterolemia
- Homozygous familial hypercholesterolemia
In development for (2)
- Hypertriglyceridemia Phase 2
- Metabolic disease Phase 1
Targets (1)
- ANGPTL3 Angiopoietin-related protein 3 inhibitor