Alirocumab is under clinical development by Regeneron Pharmaceuticals and currently in the Phase I 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 Alirocumab’s likelihood of approval (LoA) and phase transition for Septic Shock took place on 26 Jul 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Alirocumab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Alirocumab overview

Alirocumab (REGN-727, Praluent, SAR236553, Golyra, Praluent, 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) is engaged in discovering, developing, manufacturing, and marketing 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, and rare diseases. It develops products using its Trap and VelociSuite technology platforms, which include VelocImmune, VelociGene, VelociMouse, VelociMab, Veloci-Bi, and other related technologies. The company operates manufacturing facilities in Rensselaer, New York, and Limerick, Ireland. It also collaborates with strategic partners to develop, manufacture, and commercialize its products. It sells its products to specialty pharmacies and distributors. The company operates in the US, the Netherlands, Bermuda, Ireland, Spain, and the UK. Regeneron is headquartered in Tarrytown, New York, the US.

Quick View Alirocumab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Alirocumab
Administration Pathway
  • Subcutaneous
Therapeutic Areas
  • Cardiovascular
  • Infectious Disease
  • Metabolic Disorders
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

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.