Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi SA (NYSE:SNY) have moved a step closer to selling Praluent in Japan after authorities approved its authorization. The cholesterol treatment has already attained approval in the US, the European Union as well as Canada and Mexico.
Authorities in Japan have awarded the two drug makers a marketing and manufacturing authorization for the treatment of patients struggling with hypercholesterolemia. The drug can also be administered to patients with familial hypercholesterolemia if statins are not adequate.
The drug specifically targets patients struggling with high cholesterol levels which most of the time increases the risk of cardiovascular attacks. Regeneron and Sanofi say they will make Praluent 75mg and 150 mg available as a single dose.
Approval in Japan increases the addressable market for the drug, given that hypercholesterolemia is a big problem with many people struggling to achieve the desired cholesterol treatment goals. Clinical trials have already shown that Praluent has the potential to cause big reductions in LDL cholesterol compared to other treatments.
Having enrolled 216 patients for the Phase 3 ODYSSEY Japan trial, Sanofi says Praluent reduced LDL cholesterol in the patients by 63% at the end of six months. By the end of week 52, patients had averaged LDL cholesterol of 53.4 mg/dl compared to 135.6mg/dl in the placebo group.
Some of the adverse effects recorded during the clinical trials included nasopharyngitis as well as back pain and injection site reaction. However, Regeneron Pharmaceuticals VP Program Direction Bill Sasiela says results from the Phase III trial were consistent with the ODYSSEY program, 99% of the patients having attained their LDL cholesterol goals.
Praluent is designed to prevent the binding of PCSK9 to LDL receptors. This in turn results in an increase in the number of LDL receptors on the surface of liver cells which most of the time results in reduced LDL cholesterol levels.
The drug is currently being used in the US as a supplement to diet for the treatment of clinical atherosclerotic cardiovascular disease. In Europe, it is being used for the treatment of hypercholesterolemia in combination with statins.