New Praluent dosage form available at general hospitals

may be prescribed at general hospitals in Korea

The PCSK9 inhibitor Praluent was approved by drug committees (DCs) of general hospitals in Korea, including Seoul National University Hospital and Asan Medical Center

Was listed for reimbursement in April… the new once-monthly dosing schedule improves patient compliance

A new dosage form of the PCSK9 inhibitor ‘Praluent’ may be prescribed at general hospitals in Korea.

 

According to industry sources, a pen formulation of Sanofi-Aventis Korea's primary hypercholesterolemia and mixed dyslipidaemia treatment Praluent (alirocumab), Praluent Pen 300mg inj, has been approved by the Drug Committees (DCs) of tertiary hospitals in Korea, including Seoul National University Hospital, Seoul Asan Hospital, and Sinchon Severance Hospital.

 

Praluent Pen Inj 300mg maintains similar LDL-C lowering effects to the existing dosages while enabling administration at four-week (Q4W) intervals, thereby improving treatment convenience and patient compliance.

 

This drug is the only PCSK9 inhibitor in Korea available in three doses (75 mg, 150 mg, and 300 mg), and all doses are indicated for reducing cardiovascular risk in patients with atherosclerotic cardiovascular disease (ASCVD).

 

PK/PD studies confirmed the LDL-C-lowering efficacy of Praluent Pen 300mg, with LDL-C reduction effects observed as early as day 3 after a single dose of Praluent Pen 300mg injection, reaching a maximum average reduction of 73.7% by day 22.

 

This LDL-C-lowering effect was maintained for up to 43 days, demonstrating a longer duration of effect compared to the existing Praluent 75mg Pen (8 days) and 150mg (15 days).

 

Praluent 300 mg has been listed for reimbursement in Korea since April.

 

As a result, Praluent Pen Inj may be used with reimbursement when administered in addition in ▲patients with primary hypercholesterolemia and mixed dyslipidemia who have received insufficient response to combination therapy with statins and ezetimibe (LDL-C levels not reduced by at least 50% from baseline or LDL-C ≥ 100 mg/dL) and statin intolerance ▲Patients with atherosclerotic cardiovascular disease who have received maximum tolerated doses of statins and ezetimibe but have had an inadequate response (LDL-C levels not reduced by at least 50% from baseline or LDL-C ≥ 70 mg/dL).

 

In a Phase III trial (CHOICE 1) involving patients who were taking the maximum tolerated dose of statins, patients who were taking the maximum tolerated dose of statins in combination with other lipid-lowering agents, and patients who were not taking statins, the starting does of Praluent Pen 300 mg Inj demonstrated efficacy, long-term safety profile, and tolerability.

 

According to the study, at week 24, the LDL-C reduction effect of Praluent 300 mg Inj plus statin therapy compared to placebo was 58.8%, showing a statistically significant result compared to the placebo group (0.1% reduction).

 

In the case of its indication for atherosclerotic cardiovascular disease, the drug demonstrated efficacy iin the ODYSSEY OUTCOMES study.

 

The study included 18,924 adult patients with acute coronary syndrome (ACS), including myocardial infarction and unstable angina.

 

The results showed that Praluent significantly reduced the risk of major adverse cardiovascular events (MACE) by 15% compared to the placebo group.

 

A trend toward a reduction in all-cause mortality was also observed as a secondary endpoint, which was nominally significant in hierarchical statistical testing.

 

In addition, y, LDL-C achieved its maximum reduction effect at week 4 of Praluent treatment and maintained an average reduction of 54.7% after 4 years of treatment.

 

LDL-C reduction was observed in 89% of patients receiving high-intensity statins in combination with Praluent.