Alirocumab is under clinical development by Sanofi and currently in Phase II for Non-Small Cell Lung Cancer. According to GlobalData, Phase II drugs for Non-Small Cell Lung Cancer have a 38% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. 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, rare diseases, multiple sclerosis; 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 drug 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, Ile-de-France, France.

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

This content was updated on 10 June 2024

Data Insights

From

The gold standard of business intelligence.

Blending expert knowledge with cutting-edge technology, GlobalData’s unrivalled proprietary data will enable you to decode what’s happening in your market. You can make better informed decisions and gain a future-proof advantage over your competitors.

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 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.