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Sanofi Korea announced the launch of Praluent Pen 300mg (ingredient: alirocumab) on Tuesday, following its inclusion in the national health insurance reimbursement list. The new formulation is designed to provide a more convenient and effective treatment option for patients with high cholesterol and cardiovascular risk.
Sanofi Korea has launched Praluent 300mg with reimbursement coverage, offering a once-monthly treatment option to improve cholesterol control and cardiovascular risk management in high-risk patients.
Sanofi Korea has launched Praluent 300mg with reimbursement coverage, offering a once-monthly treatment option to improve cholesterol control and cardiovascular risk management in high-risk patients.
Praluent 300mg is now reimbursed for patients with primary hypercholesterolemia or mixed dyslipidemia who have shown an inadequate response to the combination of statins and ezetimibe—either by failing to achieve a 50 percent reduction in LDL-C from baseline or maintaining LDL-C levels at or above 100mg/dL—including those who are intolerant to statins.
It is also reimbursed for patients with atherosclerotic cardiovascular disease (ASCVD) whose LDL-C levels remain above target despite receiving the maximum tolerated dose of statins in combination with ezetimibe.
The newly launched 300mg dose maintains the LDL-C lowering efficacy of previous formulations, while allowing for once-every-four-weeks (Q4W) administration.
This less frequent dosing schedule is expected to enhance patient adherence and improve overall treatment satisfaction. With this addition, Praluent has become the only PCSK9 inhibitor available in Korea in three different strengths—75mg, 150mg, and 300mg—offering physicians greater flexibility to tailor treatment based on individual patient needs. All three strengths are approved for reducing cardiovascular risk in ASCVD patients.
Pharmacokinetic and pharmacodynamic data showed that Praluent 300mg begins lowering LDL-C as early as day three, with a maximum average reduction of 73.7 percent observed by day 22. This effect was sustained for up to 43 days, significantly longer than the durations seen with the 75mg and 150mg doses, which last eight and fifteen days, respectively.
The efficacy, safety, and tolerability of the 300mg formulation were also demonstrated in the phase 3 CHOICE 1 clinical trial. The study showed that after 24 weeks of treatment, patients receiving Praluent 300mg in combination with statins experienced an average LDL-C reduction of 58.8 percent from baseline, compared to just 0.1 percent in the placebo group.
Further supporting the drug’s cardiovascular benefits, the ODYSSEY OUTCOMES study involved 18,924 adult patients with acute coronary syndrome, including myocardial infarction and unstable angina.
The trial showed that Praluent reduced the risk of major adverse cardiovascular events (MACE) by 15 percent compared to placebo. A trend toward reduced all-cause mortality was also observed and reached nominal statistical significance.
At week four, Praluent achieved peak LDL-C lowering, and after four years of treatment, it maintained an average reduction of 54.7 percent. Among patients receiving high-intensity statins, 89 percent continued to experience LDL-C lowering.
“LDL-C is a major modifiable risk factor for cardiovascular disease, the leading cause of death globally. In high-risk patients, more intensive management is essential,” said Bae Kyung-eun, General Manager Pharma Multi-Country Office South Korea and Austrailia/New Zealand & MCO Lead. “With the reimbursement of Praluent 300mg, we are providing Korean patients—especially those who struggled to achieve LDL-C targets or had difficulty with frequent dosing—with a more effective and convenient treatment option.”
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Lee Han-soo corea022@docdocdoc.co.kr
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