Alirocumab (trade name Praluent) is an experimental human monoclonal antibody PCSK9 inhibitor designed for the treatment of hypercholesterolemia. It is also known as [1 ] REGN727 and SAR236553. It was discovered by [2 ] Regeneron Pharmaceuticals and is being co-developed with Sanofi. A main competitor in the race to worldwide health authority approval is evolocumab in development by Amgen.
Clinical trials [ edit ]
A phase 3 trial of statin intolerant patients called ODYSSEY ran for 65 weeks.
Results were presented at the 2014 European Society of Cardiology meeting. [3 ] [4 ]
A 78-week study of alirocumab in 2341 people taking statins who were at high risk for cardiovascular events and had high LDL cholesterol levels was published in April 2015.
References [ edit ]
^ International Nonproprietary Names for Pharmaceutical Substances (INN), World Health Organization
^ Sheridan, C (2013). "Phase 3 data for PCSK9 inhibitor wows". Nature Biotechnology 31 (12): 1057–8. doi: 10.1038/nbt1213-1057. PMID 24316621.
^ "Efficacy and safety of alirocumab, a monoclonal antibody to PCSK9, in statin-intolerant patients: Design and rationale of ODYSSEY ALTERNATIVE, a randomized phase 3 trial.". Journal of Clinical Lipidology 8: 554–61. Nov–Dec 2014. doi: 10.1016/j.jacl.2014.09.007. PMID 25499937.
^ "Huge Decreases in LDL Cholesterol With Alirocumab: ODYSSEY".
^ Robinson, Jennifer G.; Farnier, Michel; Krempf, Michel; Bergeron, Jean; Luc, Gérald; Averna, Maurizio; Stroes, Erik S.; Langslet, Gisle; Raal, Frederick J. (April 16, 2015). "Efficacy and Safety of Alirocumab in Reducing Lipids and Cardiovascular Events". New England Journal of Medicine 372 (16): 1489–1499. doi: 10.1056/NEJMoa1501031. ISSN 0028-4793. PMID 25773378.