pharma · Small Cell Lung Cancer · Metastatic castration-resistant prostate cancer (mCRPC)
Amgen is a pharma organization headquartered in Thousand Oaks, USA. Primary therapeutic focus areas include Small Cell Lung Cancer, Metastatic castration-resistant prostate cancer (mCRPC), Cardiovascular Disease, Colorec
Approved · small molecule · Dyslipidemia
Evolocumab (brand name REPATHA) is an approved injectable therapeutic for dyslipidemia, sponsored by Amgen. The drug is a small-molecule modality indicated for cardiovascular risk reduction in patients with elevated lipid levels. Evolocumab has achieved regulatory approval across major markets including the United Stat
Internal code 20190184
Evolocumab (brand name REPATHA) is an approved injectable therapeutic for dyslipidemia, sponsored by Amgen. The drug is a small-molecule modality indicated for cardiovascular risk reduction in patients with elevated lipid levels. Evolocumab has achieved regulatory approval across major markets including the United States (BLA125522), European Union (EMEA/H/C/003766, authorized 12 December 2025), Japan (approved January 2016), and Australia (first listed 1 December 2016). The program maintains active development status with ongoing clinical investigation, most notably the EVOLVE-MI trial—a pragmatic randomized multicenter study evaluating very early administration in acute myocardial infarction patients hospitalized for cardiovascular events. Amgen's strategy centers on expanding the clinical evidence base for evolocumab beyond standard dyslipidemia management into acute coronary syndromes. The therapeutic class is cardiovascular system (C10), administered via injection. Current regulatory status reflects mature market penetration with multiple approved formulations across geographies, supported by established manufacturing and distribution infrastructure through Amgen Australia Pty Limited, Amgen Europe B.V., and Amgen Inc.
Dyslipidemia remains a leading modifiable cardiovascular risk factor globally, with millions of patients requiring intensive lipid-lowering therapy to prevent myocardial infarction and stroke. The unmet medical need encompasses patients with inadequate response to statins, statin intolerance, and those with familial hypercholesterolemia requiring aggressive LDL reduction. Evolocumab addresses this need by offering an injectable option for patients requiring additional lipid control beyond oral agents. Market relevance is substantial given the prevalence of cardiovascular disease and the aging population in developed economies. Competitive positioning reflects a crowded dyslipidemia landscape with multiple approved agents including PRALUENT (Regeneron), LEQVIO (Novartis), EVKEEZA (Ultragenyx), and NILEMDO (Esperion), among others. The EVOLVE-MI trial expansion into acute myocardial infarction represents a strategic effort to differentiate evolocumab through evidence of early intervention benefit in acute settings, potentially expanding the addressable patient population beyond chronic dyslipidemia management. Commercial significance derives from the chronic, high-volume nature of dyslipidemia treatment and the premium pricing typical of injectable lipid-lowering therapies. Patient population includes those with elevated LDL cholesterol despite maximum tolerated statin therapy, familial hypercholesterolemia, and increasingly, acute coronary syndrome patients where rapid lipid reduction may confer clinical benefit.
Drug Class: Lipid-lowering agent, cardiovascular system therapeutic (C10).
Modality: Small-molecule injectable.
Route of Administration: Injection (subcutaneous or intravenous formulations).
Mechanism of Action: Not yet disclosed in available facts.
Target: Not yet disclosed in available facts.
Brand Name: REPATHA.
International Nonproprietary Name (INN): Evolocumab.
Related Therapies: Competing agents in the dyslipidemia space include PRALUENT (Regeneron), LEQVIO (Novartis), EVKEEZA (Ultragenyx), NILEMDO (Esperion), KYNAMRO, LOJUXTA, WAYLIVRA, and REDEMPLO (Arrowhead). Combination therapy with statins and ezetimibe remains standard of care.
First Approval: Japan (January 2016); Australia (1 December 2016); United States and European Union approvals followed.
Patent Status: Not yet disclosed in available facts.
Also known as: disorder of lipid metabolism, dyslipidaemia, dyslipidemia, lipid metabolism disorder
An inherited metabolic disorder caused by an enzyme deficiency, resulting in an inability to oxidize fatty acids for energy production.
ClinicalTrials.gov lists 14 registered studies for Lipid Metabolism Disorder (AACT aggregate).
Phase breakdown: NA (11), PHASE1 (1), PHASE3 (1), PHASE4 (1)
Common investigational therapies:
Disease data sourced from MONDO Disease Ontology (MONDO:0002525), Orphanet — inherited lipid metabolism disorder, NCT00651963, NCT01071278, NCT02603770, NCT03236116, NCT03392701, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
Japan approval
Evolocumab approved in Japan by PMDA.
Australia approval (first listing)
Evolocumab first listed on Australian ARTG with PBS code 10958R.
Australia additional listing
Additional Australian PBS listing with code 11484K.
Australia additional listing
Further Australian PBS listing with code 11977J.
European Union authorization
Evolocumab authorized by EMA (EMEA/H/C/003766).
EVOLVE-MI trial results
Pragmatic randomized multicenter trial evaluating evolocumab administered very early in acute myocardial infarction.
Evolocumab operates within a competitive dyslipidemia market featuring multiple approved therapeutic options. PRALUENT (Regeneron UK Limited) represents a direct injectable competitor with approved status. LEQVIO (Novartis Pharmaceuticals) offers an alternative mechanism for LDL reduction. EVKEEZA (Ultragenyx UK Limited), NILEMDO (Esperion Therapeutics), and REDEMPLO (Arrowhead Pharmaceuticals Ireland Limited) provide additional approved choices. Oral agents including APO-FENOFIBRATE (Viatris Pharmaceuticals Co.) and VAZKEPA (Seqirus Australia Pty Ltd) address complementary lipid parameters. Older therapies such as KYNAMRO, LOJUXTA, WAYLIVRA, TREVACLYN, and CHOLESTAGEL remain approved but face declining utilization. Evolocumab's competitive differentiation strategy centers on the EVOLVE-MI trial, which investigates early intervention in acute myocardial infarction—a potential label expansion that would distinguish it from competitors focused primarily on chronic dyslipidemia management. The crowded landscape reflects substantial unmet medical need but also intense competition for market share, pricing pressure, and the requirement for robust clinical evidence to justify premium positioning.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| PRALUENT | Regeneron UK Limited | — | approved |
| REDEMPLO | Arrowhead Pharmaceuticals Ireland Limited | — | approved |
| VAZKEPA | Seqirus (Australia) Pty Ltd | — | approved |
| APO-FENOFIBRATE | Viatris Pharmaceuticals Co., | — | approved |
| NILEMDO | Esperion Therapeutics | — | approved |
| EVKEEZA | Ultragenyx UK Limited | — | approved |
| KYNAMRO | — | — | approved |
| TREVACLYN | — | — | approved |
| CHOLESTAGEL | — | — | approved |
| LEQVIO | Novartis Pharmaceuticals | — | approved |
| LOJUXTA | — | — | approved |
| WAYLIVRA | — | — | approved |
| VOLANESORSEN SODIUM | — | Apolipoprotein C-III mRNA antisense inhibitor | Approved |
| TORIPALIMAB | — | Programmed cell death protein 1 antagonist | Approved |
| SIMVASTATIN | — | HMG-CoA reductase inhibitor | Approved |
| ROSUVASTATIN CALCIUM | — | HMG-CoA reductase inhibitor | Approved |
| PREDNISONE | — | Glucocorticoid receptor agonist | Approved |
| PREDNISOLONE | — | Glucocorticoid receptor agonist | Approved |
| PRAVASTATIN SODIUM | — | HMG-CoA reductase inhibitor | Approved |
| PITAVASTATIN CALCIUM | — | HMG-CoA reductase inhibitor | Approved |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
United States: Approved via BLA125522 (Biologics License Application). Sponsor: AMGEN INC. Status: Approved.
European Union: Authorized by EMA with product number EMEA/H/C/003766. Marketing Authorization Holder: Amgen Europe B.V. Authorization date: 12 December 2025. Status: Approved.
Japan: Approved by PMDA (Pharmaceuticals and Medical Devices Agency). Approval date: January 2016. Status: Approved.
Australia: Approved and listed on ARTG (Australian Register of Therapeutic Goods). Sponsor: Amgen Australia Pty Limited. PBS codes: 10958R (first listed 1 December 2016), 11484K (listed 1 November 2018), 11977J (listed 1 May 2020), 11985T. Status: Approved.
China: Clinical trials ongoing. NCT IDs: NCT04100434, NCT06364124. Status: Clinical trials phase (not yet approved).
Expected Loss of Exclusivity (LOE): Not yet disclosed in available facts.
Evolocumab is an injectable lipid-lowering therapy indicated for dyslipidemia, used to reduce elevated cholesterol levels in patients who require additional lipid control beyond oral medications such as statins.
Yes, evolocumab is FDA-approved via Biologics License Application (BLA) 125522 sponsored by Amgen Inc.
The brand name is REPATHA.
Amgen manufactures evolocumab, with regional operations including Amgen Inc. (United States), Amgen Europe B.V. (European Union), and Amgen Australia Pty Limited (Australia).
Evolocumab is administered via injection (subcutaneous or intravenous formulations).
The specific mechanism of action is not yet disclosed in available regulatory or clinical documentation.
The molecular target is not yet disclosed in available facts.
Evolocumab was first approved in Japan in January 2016, followed by Australia (December 2016), and subsequently in the United States and European Union.
Yes, evolocumab is authorized by the European Medicines Agency (EMA) with product number EMEA/H/C/003766, authorized on 12 December 2025, with Marketing Authorization Holder Amgen Europe B.V.
EVOLVE-MI is a pragmatic randomized multicenter trial evaluating evolocumab administered very early to reduce the risk of cardiovascular events in patients hospitalized with acute myocardial infarction.
Competitors include PRALUENT (Regeneron), LEQVIO (Novartis), EVKEEZA (Ultragenyx), NILEMDO (Esperion), REDEMPLO (Arrowhead), and older agents such as KYNAMRO, LOJUXTA, and WAYLIVRA.
Yes, evolocumab is approved and listed on the Australian Register of Therapeutic Goods (ARTG) with multiple PBS codes (10958R, 11484K, 11977J, 11985T) and is distributed by Amgen Australia Pty Limited.
Evolocumab is not yet approved in China; clinical trials are ongoing (NCT04100434, NCT06364124).
Evolocumab belongs to the cardiovascular system therapeutic class (C10) and is classified as a lipid-lowering agent.
The internal program code is 20190184.
No partner or co-development agreement is disclosed in available facts; Amgen is the sole sponsor.
EVOLOCUMAB → Drug → Target → Indication → Company → Trials → Competitors
Strategic Implications: Amgen's continued investment in the EVOLVE-MI trial signals a strategic pivot toward acute coronary syndrome indications, moving beyond the mature chronic dyslipidemia market. This expansion addresses a clinically relevant question—whether very early lipid reduction in acute MI improves outcomes—and could unlock a new patient population and revenue stream if positive results emerge. The trial's pragmatic design enhances real-world applicability and regulatory credibility.
Competitive Implications: The dyslipidemia market remains highly competitive with multiple approved agents. Evolocumab's differentiation through acute MI data would provide competitive advantage over PRALUENT and LEQVIO in this specific indication, though mechanism-based differences among competitors remain undisclosed. Market share dynamics will depend on trial outcomes, pricing, and payer coverage decisions.
Future Catalysts: The primary catalyst is EVOLVE-MI trial readout, which could support label expansion into acute myocardial infarction. Additional catalysts include regulatory decisions in China (NCT04100434, NCT06364124 ongoing), potential formulation improvements, and real-world evidence generation. Patent expiration dates and biosimilar entry timelines are not yet disclosed.
Expected Milestones: EVOLVE-MI results publication and potential FDA/EMA label expansion represent the most significant near-term milestones. China regulatory approval following completion of NCT04100434 and NCT06364124 would extend geographic reach. Ongoing PBS listing updates in Australia suggest continued market access optimization.
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Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.