Evolocumab is a Monoclonal Antibody owned by Amgen, and is involved in 82 clinical trials, of which 55 were completed, 21 are ongoing, and 6 are planned.

Evolocumab (AMG-145) bind to PCSK9 and inhibit PCSK9 from binding to LDL receptors on the liver surface. In the absence of PCSK9, there are more LDL receptors on the surface of the liver to remove LDL-C from the blood. In the hepatocyte, PCSK9 undergoes an obligatory autocatalytic cleavage in the endoplasmic reticulum before being secreted, but its catalytic activity is not required for its ability to modulate LDL-R surface expression. Rather, PCSK9 is secreted into plasma by hepatocytes and acts by binding to the LDL-R extracellularly, being internalized with it and facilitating its enhanced degradation. PCSK9 does not itself degrade the LDL-R but binds tightly to it and channels it toward the lysosomal compartment for degradation. Thus, it inhibits the recycling of the LDL-R back to the cell surface, which results in decreased LDL-R number. Blocking PCSK9 binding to the LDL-R can profoundly lower plasma LDL levels.

The revenue for Evolocumab is expected to reach a total of $1.3bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Evolocumab NPV Report.

Evolocumab is originated and owned by Amgen. Astellas Pharma is the other company associated in development or marketing of Evolocumab.

Evolocumab Overview

Evolocumab (AMG-145, Repatha) is a monoclonal antibody acts as lipid modifying agent. It is formulated as injection solution for subcutaneous route of administration. Repatha is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of pediatrics, adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (CVD), who require additional lowering of  low density lipoprotein cholesterol (LDL-C), as an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) for the treatment of pediatric and adult patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL-C, in adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia, as an adjunct to diet in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated and also indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolemia in combination with other lipid-lowering therapies, also indicated to reduce  the risk of myocardial infarction, stroke, coronary revascularization in adults with established cardiovascular disease, and for treating hypercholesterolemia patients who are not suitable for HMG-CoA reductase inhibitor (statin) therapy.

Evolocumab is under development for the treatment of homozygous familial hypercholesterolemia and heterozygous familial hypercholesterolemia (HeFH) in pediatrics and hypercholesterolemia.

Astellas Pharma Overview

Astellas Pharma (Astellas) discovers, develops, manufactures, and commercializes a wide range of pharmaceuticals. The company’s product portfolio comprises marketed products for the treatment of a wide range of urological diseases, infectious diseases, cancer, nephrology, and metabolic diseases, immunodeficiency diseases, and transplantation. Its pipeline possesses drug candidates for the treatment of urothelial cancer; gastric cancer; gastroesophageal junction cancer; anemia associated with chronic kidney disease (CKD) in dialysis; Rheumatoid arthritis and non-dialysis patients; menopause-related vasomotor symptoms (MR-VMS) such as hot flashes and night sweats; and acute myeloid leukemia (AML), among others. It operates in the Americas, Australia, Europe, and Asia and Oceania through a network of subsidiaries and affiliates. Astellas is headquartered in Tokyo, Japan.

The company reported revenues of (Yen) JPY1,296,163 million for the fiscal year ended March 2022 (FY2022), an increase of 3.7% over FY2021. In FY2022, the company’s operating margin was 12.4%, compared to an operating margin of 11.7% in FY2021. In FY2022, the company recorded a net margin of 9.6%, compared to a net margin of 9.7% in FY2021. The company reported revenues of JPY380,394 million for the second quarter ended September 2022, a decrease of 0.4% over the previous quarter.

Quick View – Evolocumab

Report Segments
  • Innovator (NME)
Drug Name
  • Evolocumab
Administration Pathway
  • Subcutaneous
Therapeutic Areas
  • Cardiovascular
  • Metabolic Disorders
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.