Alirocumab is under clinical development by Sanofi and currently in Phase I for Septic Shock. According to GlobalData, Phase I drugs for Septic Shock have an 89% 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.

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.

Sanofi overview

Sanofi is a healthcare company, which is engaged in the discovery, development, manufacturing and marketing of a wide range of medicines and vaccines. Its portfolio includes medicines for the treatment of cancer, diabetes, rare diseases, multiple sclerosis and cardiovascular diseases; human vaccines for protection against various bacterial and viral diseases; and other products. The company also offers consumer healthcare products for digestion; allergy; cough, cold, flu and sinus; pain; women’s health; and vitamins, minerals and supplements. Sanofi‘s R&D efforts focus on advancing a combination drugs to increase the effectiveness of treatments and on advancing the formulation of new biologics to produce precision medicines. It has operations in Europe, the Americas, Asia-Pacific, Africa and the Middle East. Sanofi is headquartered in Paris, France.

For a complete picture of Alirocumab’s drug-specific PTSR and LoA scores, buy the report here.

GlobalData

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 its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.