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항목
AntibodyCurated CoreFDAApproved
evolocumab (Repatha, AMG-145)
Amgen·PCSK9
143 trials·t½ 17 h
Overview
Program
Repatha (evolocumab)
Overview
Company
Amgen
Overview
Modality
ANTIBODY
Overview
Target
PCSK9
Overview
Indication
Hyperlipidemia, ASCVD risk reduction, HeFH, HoFH
Overview
Phase
APPROVED
Overview
Status
APPROVED
Overview
Content status
Curated Core
Overview
Data Confidence
Data Confidence · High
Overview
Development Signal
Development Signal · Established
Overview
Approval status
FDA approved
Positioning
Key differentiator
High LDL-C lowering without statin myalgia; autoinjector pen
Positioning
Known limitation
Statin non-adherence; rare anti-drug antibodies
Positioning
Development positioning
PCSK9 mAb vs inclisiran siRNA (Leqvio) dosing convenience trade-off
MoA
Mechanism
Evolocumab binds PCSK9, preventing PCSK9-mediated LDL receptor degradation on hepatocytes, increasing LDLR recycling and hepatic LDL-C clearance.
MoA
Biomarker
LDL-C, ApoB, non-HDL-C; Lp(a) modest reduction.
PK/PD
Half-life
17 h
PK/PD
Species
Mouse
PK/PD
Animal (cat.)
Mouse, In vitro
PK/PD
Experiment
pharmacokinetic
Toxicology
Species
Cynomolgus monkey, Mouse, Hamster
Toxicology
Animal (cat.)
NHP
Toxicology
Major finding
No major organ toxicity; injection-site reactions
Toxicology
CRS
N/A
Clinical
Safety signal
No major organ toxicity; injection-site reactions
Clinical
Selected reported efficacy
67%
Clinical
Result source
ClinicalTrials.gov NCT05144529
Clinical
Program phase
APPROVED
Clinical
Trial activity
No active/completed counts
Clinical
Trial ref
NCT05144529
Preclinical
Animal (cat.)
Mouse, In vitro