US-based Regeneron Pharmaceuticals and French pharmaceutical company Sanofi have received marketing and manufacturing authorisation from the Ministry of Health, Labour and Welfare in Japan for Praluent (alirocumab).
Praluent (alirocumab) is a human monoclonal antibody that targets proprotein convertase subtilisin / kexin type 9 (PCSK9).
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It has been granted authorisation for the treatment of uncontrolled low-density lipoprotein (LDL) cholesterol in some adult patients with hypercholesterolemia at high-cardiovascular risk.
In Japan, Praluent is indicated to treat patients affected with hypercholesterolemia and familial hypercholesterolemia (FH) who are at high-cardiovascular risk, and in whom treatment with statins (HMG-CoA reductase inhibitors) is not sufficient.
The treatment in 75mg and 150mg will be available in Japan as a single-dose pre-filled pen and syringe.
Sanofi cardiovascular development head Dr Jay Edelberg 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.
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By GlobalData“For these patients, Praluent could be an important treatment option to help address their needs.”
The global Phase III ODYSSEY trials demonstrated consistent and significant reductions in LDL cholesterol for Praluent compared to placebo, when added to current standard-of-care, which included maximally-tolerated statins.
Regeneron programme direction vice-president Dr Bill Sasiela said: “Results from the Japanese Phase III trial were consistent with the findings from our global ODYSSEY programme 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 75mg Q2W and maintain these reductions for the duration of their therapy, up to 52 weeks.”
Praluent is approved in the US, European Union (EU), Canada and Mexico.
However, the effect of Praluent on cardiovascular morbidity and mortality is yet to be determined.
