Leqvio may reshape the mkt for statin-intolerant patients

Twice-yearly physician-administered injection shows improved treatment outcomes

Introduces a new direction in lipid-lowering therapy (LLT) strategy with its LDL-C-lowering effect

Leqvio, the dyslipidemia treatment administered once every six months, is rapidly expanding its presence by targeting niche patient segments.

 

The treatment is gaining traction, particularly among patients with statin intolerance, those with a family history of dyslipidemia, and those who prefer a biannual, physician-administered injection schedule.

 

Novartis Korea’s Leqvio (inclisiran) is the first-in-class siRNA therapy approved in Korea.

 

It received domestic approval in June 2024 as an adjunct to diet for patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) or mixed dyslipidemia.

 

Leveraging naturally occurring siRNA mechanisms, Leqvio inhibits the production of PCSK9, a protein that increases LDL cholesterol, thereby reducing circulating LDL-C levels.

 

A key advantage is its twice-yearly administration by healthcare professionals, which removes the burden and fear associated with self-injection.

 

Experts note that Leqvio’s introduction brings more than just improved convenience.

 

Professor Young Bin Song of the Department of Cardiology at Samsung Medical Center said, "Leqvio effectively lowers LDL-C with just two injections per year, fundamentally changing the strategy of lipid-lowering therapy (LLT).

 

Maintaining lowered LDL-C levels over the long term plays a crucial role in reducing cardiovascular disease risk.

 

Therefore, the 6-month dosing interval offers value that goes beyond convenience.” Leqvio specifically targets patients with statin intolerance, addressing the unmet need in the existing dyslipidemia treatment market dominated by statins.

 

Currently, 39% of Korean patients with high cholesterol levels do not use lipid-lowering drugs, which inevitably increases their risk of cardiovascular disease.

 

Professor Song said, “High-intensity statins, the first-line LLT, require daily administration.

 

Unfortunately, patient adherence rates are not high.

 

Discontinuation often occurs due to adverse reactions like liver or kidney function impairment, muscle pain, or daily inconvenience from muscle pain, creating challenges in lipid management.” Meanwhile, the results of the V-DIFFERENCE study, a Phase 4 clinical trial evaluating the LDL-C target achievement rate in patients with hypercholesterolemia who received either LLT optimized for individual patients plus Leqvio or LLT plus placebo, were recently presented at the European Society of Cardiology Congress (ESC 2025).

 

This study holds significance as the first to evaluate Leqvio’s effect on muscle symptoms and pain commonly observed in patients receiving statins and other LLT treatments.

 

Secondary endpoints included the proportion of patients experiencing at least one muscle-related adverse event (MRAE) after 360 days of treatment and the proportion reporting self-reported pain.

 

Results showed that the Leqvio treatment group achieved significantly higher rates of individual LDL-C target attainment compared to the placebo group.

 

Furthermore, the likelihood of muscle-related adverse events (MRAEs) was 43% lower in the Leqvio group than in the placebo group, and numeric improvements were also observed in pain-related quality of life (QoL) scores.

 

Professor Song stated, “Given that some patients undergoing statin therapy suffer from side effects like muscle pain, this study reaffirms that Leqvio can serve as a viable treatment option that can address the unmet needs of existing LLT strategies.”