Sanofi, Regeneron say cholesterol drug Praluent approved in Japan
pharmafile | July 5, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | Japan, Regeneron, Sanofi, cardiovascular, cholestrol, praleunt
Sanofi (Euronext: SAN) and Regeneron Pharmaceuticals (Nasdaq: REGN) said the lawmakers in Japan have granted marketing and manufacturing authorization for cholesterol drug Praluent (alirocumab).
The Ministry of Health, Labor and Welfare in Japan granted marketing and manufacturing authorization for Praluent to treat patients with hypercholesterolemia at high cardiovascular risk, the companies said in a joint statement.
Jay Edelberg, head of cardiovascular development, Sanofi, said: “Hypercholesterolemia is a significant concern in Japan, and many patients are not able to achieve their LDL cholesterol treatment goals despite current lipid-lowering therapy. For these patients, Praluent could be an important treatment option to help address their needs.”
Data from a global Phase III trial showed consistent, robust reductions in LDL cholesterol for Praluent compared to placebo, when added to current standard-of-care, which included maximally-tolerated statins.
Bill Sasiela, VP, program direction, Regeneron, said: “Results from the Japanese Phase III trial were consistent with the findings from our global Odyssey program that evaluated the efficacy and safety of Praluent in patients who required further reduction of their LDL cholesterol. Notably, in the Odyssey Japan trial, 99% of patients were able to effectively reach their LDL cholesterol goals as defined by the Japan Atherosclerosis Society with Praluent 75 mg Q2W and maintain these reductions for the duration of their therapy, up to 52 weeks.”
Praluent inhibits the binding of PCSK9 to the LDL receptor and thereby increases the number of available LDL receptors on the surface of liver cells, which results in lower LDL cholesterol (so-called bad cholesterol) levels in the blood.
In July 2015, the companies announced that Praluent was approved for use in the US as adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL cholesterol.
In September 2015, the European Commission approved the marketing authorization for Praluent.
Anjali Shukla
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