Sanofi launches new dosage form of Praluent with reimb

The only PCSK9 inhibitor in Korea that offers three dosage forms

Maintains the effect of reducing LDL-C and continued treatment effect with 4-week intervals

Pic of Praluent

Sanofi announced on the 1st that a 300 mg dose form of its PCSK9 inhibitor Praluent (alirocumab) will be launched in April with health insurance reimbursement in Korea.

 

According to this announcement, Praluent 300 mg may now be reimbursed when used in patients with primary hypercholesterolemia and mixed dyslipidemia who have been administered a combination of statins and ezetimibe but have not responded sufficiently (LDL-C levels have not decreased by 50% or more from the baseline or LDL-C ≥ 100 mg/dL) and in cases of statin intolerance.

 

In addition, if a patient with atherosclerotic cardiovascular disease has received a combination of the maximum tolerated dose of a statin and ezetimibe but has not responded sufficiently (LDL-C level has not decreased by more than 50% from the baseline or LDL-C ≥ 70 mg/dL), the patient may be eligible for health insurance reimbursement for his/her additional use of Praluent.

 

While maintaining the LDL-C lowering effect similar to the existing dose, Praluent 300 mg allows administration at 4-week (Q4W) intervals, increasing treatment convenience and patient compliance.

 

With the reimbursed launch, Praluent has become the only PCKS9 inhibitor in Korea to offer 3 doses: 75 mg, 150 mg, and 300 mg.

 

As a result, Praluent has been approved for the treatment of cardiovascular risk reduction in patients with atherosclerotic cardiovascular disease (ASCVD) at all doses.

 

This will enable personalized treatment for patients, allowing healthcare professionals to select the appropriate dose according to the patient's treatment goals and individual characteristics.

 

The LDL-C-lowering effect of Praluent 300 mg was confirmed through the PK/PD study.

 

It showed an LDL-C-lowering effect from the third day after a single dose, recording a maximum average reduction of 73.7% on the 22nd day.

 

This LDL-C lowering effect was maintained for 43 days, showing a longer-lasting effect than the existing Praluent 75 mg (lasting 8 days) and 150 mg (lasting 15 days).

 

The background is that “LDL-C is a strong risk factor for cardiovascular disease, the number one cause of death worldwide, therefore thorough management is essential, especially in high-risk patients,” said Kyung-Eun Bae, General Manager of Sanofi Korea.

 

“With the launch of the 300 mg dose of Praluent, we expect to provide a more effective and convenient additional treatment option for Korean patients who have been unable to sufficiently control their LDL-C levels with existing treatments or who have found it difficult to manage their medication schedules.” “Sanofi will continue to efforts save lives and improve the quality of life of patients in Korea through our integrated cardiovascular disease treatment portfolio, which includes Praluent,” added Bae.