Evolocumab is under clinical development by Amgen and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.
According to GlobalData, the latest event to affect Evolocumab’s likelihood of approval (LoA) and phase transition for Hypercholesterolemia took place on 25 Jan 2021, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.
GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Evolocumab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.
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.
Amgen is a biotechnology company, which discovers, develops, manufactures, and markets innovative human medicines to treat patients suffering from serious diseases. It develops novel medicines in six focused disease areas including cardiovascular diseases, oncology/hematology, inflammation, bone health, neurological disorders and nephrology. The company develops products using advanced human genetics to unravel the difficulties of disease and understand the fundamentals of human biology. Amgen sells products primarily to pharmaceutical wholesale distributors in the US. It also markets certain products directly to consumers through direct-to-consumer channels such as print, television and online media. Amgen is headquartered in Thousand Oaks, California, the US.
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