Novartis' dyslipidemia treatment Leqvio Prefilled Syringe (ingredient: inclisiran sodium) won regulatory approval in Korea.

The Ministry of Food and Drug Safety said on Thursday that it granted marketing approval for Leqvio, an injectable siRNA for the treatment of dyslipidemia, as an adjunct to diet in patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia.

Leqvio can be used in combination with existing therapies in patients with dyslipidemia uncontrolled by first-line statin drugs such as atorvastatin, simvastatin, and rosuvastatin.

After the initial two injections in three-month intervals, Leqvio dosing is reduced to every six months to improve adherence.

Leqvio is the first licensed siRNA treatment in Korea. Leqvio's main ingredient, inclisiran sodium, is a chemically synthesized double-helix siRNA. It reduces blood low-density lipoprotein cholesterol (LDL-C) levels by inhibiting the synthesis of the PCSK9 protein in liver cells.

The approval was based on the phase 3 clinical trials -- ORION-9, ORION-10 and ORION-11 -- in patients with atherosclerotic cardiovascular disease (ASCVD) or equivalent risk to ASCVD or heterozygous familial hypercholesterolemia (HeFH).

The ORION-9, ORION-10, and ORION-11 studies were double-blind, randomized, placebo-controlled trials that evaluated the efficacy and safety of Leqvio. 

At Day 510, LDL-C was reduced by 47.9 percent, 52.3 percent, and 49.9 percent in the Leqvio arm compared to placebo (P<0.001), respectively.

In all three studies, the safety profile of REVIO and placebo was not significantly different, and Levio demonstrated effective LDL-C reduction and a favorable long-term safety profile in patients who received Leqvio for up to 6.8 years in clinical trials.

Approximately 78 percent of acute myocardial infarction patients in Korea do not achieve LDL-C target levels within one year, and these patients are associated with a 49 percent increase in total cardiovascular events. Patients who have experienced a myocardial infarction are five to seven times more likely to have a subsequent heart attack.

Cho Yeon-jin, head of CVD & NGTx at Novartis Korea, said Leqvio would be an innovative alternative in Korea where approximately 75 of ASCVD patients who require additional LDL-C management do not reach their target LDL-C levels.

The ministry said Leqvio was expected to provide new treatment options for patients with dyslipidemia. It added that it would ensure therapies with sufficiently confirmed safety and effectiveness are quickly supplied and patients have access to expanded treatment opportunities.