Alirocumab is under clinical development by Regeneron Pharmaceuticals and currently in Phase I for Sepsis. According to GlobalData, Phase I drugs for Sepsis have an 81% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Alirocumab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
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GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Alirocumab overview
Alirocumab (REGN-727, Praluent, SAR236553, Golyra, Praluent Pen, Eliriduc) is a monoclonal antibody acts as a cholesterol-lowering agent. It is formulated as solution and suspension for subcutaneous route of administration. Praluent is indicated in treatment in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH) or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, and is indicated in adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated, and to reduce the risk of myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular diseases.
Alirocumab is under development for the treatment of sepsis and septic shock, acute ischemic stroke, non-small cell lung cancer, intracranial atherosclerotic disease, heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (hoFH), hypercholesterolemia, first-line hyperlipidemia (in the U.S.) and for the prevention of coronary heart disease risk events (in the U.S. and EU). It is formulated as a solution and administered through the subcutaneous route.
Regeneron Pharmaceuticals overview
Regeneron Pharmaceuticals (Regeneron) discovers, develops, manufactures, and markets medicines for the treatment of serious medical conditions. Its products are focused on helping patients suffering from cancer, allergic and inflammatory diseases, eye diseases, metabolic and cardiovascular diseases, infectious diseases, neuromuscular diseases, hematologic conditions, pain, and rare diseases. Regeneron develops products using its Trap and VelociSuite technology platforms, which include VelocImmune, VelociGene, VelociMouse, VelociMab, Veloci-Bi, VelociT, and other related technologies. The company operates manufacturing facilities in Rensselaer, New York, and Limerick. It also collaborates with strategic partners to develop, manufacture and commercialize its products. The company sells its products to specialty pharmacies and distributors. It operates in the US, the Netherlands, Bermuda, Ireland, Spain, India, Japan and the UK. Regeneron is headquartered in Tarrytown, New York, the US.
For a complete picture of Alirocumab’s drug-specific PTSR and LoA scores, buy the report here.
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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
