JW Pharmaceutical Proves Lipid Improvement Effect of Livalojet in Phase 3 Clinical Trial... Application for Product Approval Submitted

Combination Drug for Dyslipidemia Treatment

[Asia Economy Reporter Kim Ji-hee] JW Pharmaceutical is strengthening its lineup of pitavastatin-based combination drugs and targeting the rapidly growing cardiovascular disease combination drug market.

JW Pharmaceutical announced on the 22nd that 'Rivarozet,' a combination drug being developed for dyslipidemia, has completed Phase 3 clinical trials in Korea and has applied for marketing approval. Rivarozet is a two-drug combination that combines pitavastatin and ezetimibe, two components used to treat dyslipidemia. This is the first time a combination drug containing pitavastatin and ezetimibe has been developed in the global market.

Pitavastatin, the basis of the combination drug, not only has preventive effects on cardiovascular disease but also has safety related to diabetes. In 31 countries overseas, the drug label (SmPC) for Livaro includes the phrase 'no signs of diabetes risk,' which is unique among statins.

Since 2019, JW Pharmaceutical has conducted Phase 3 clinical trials of Rivarozet on 283 patients with primary hypercholesterolemia at 25 hospitals nationwide, including Gangdong Sacred Heart Hospital. The Phase 3 trial divided the subjects into a monotherapy group with Livaro (pitavastatin) and a combination therapy group with Rivarozet (pitavastatin + ezetimibe), and tracked changes in LDL cholesterol levels after 8 weeks. As a result, at 8 weeks after administration, the Livaro group showed about a 37% reduction in LDL cholesterol, while the Rivarozet group showed about a 53% reduction.

Rivarozet also demonstrated superior effects compared to monotherapy in other auxiliary lipid indicators, including total cholesterol (TC) and non-HDL cholesterol (Non-HDL-C), which includes high-density lipoprotein cholesterol (HDL), confirming that combination therapy improves treatment outcomes more than monotherapy. In terms of safety, including adverse reactions, there was no significant difference compared to monotherapy.

JW Pharmaceutical plans to strengthen its lineup of cardiovascular metabolic disease treatments based on Livaro (pitavastatin). Livarov (pitavastatin·valsartan) was launched in 2015, and besides Rivarozet, which has applied for marketing approval this time, a triple combination drug is scheduled to enter clinical trials this year.

According to the pharmaceutical research institute Ubist, the prescription amount for lipid-lowering combination drugs last year was 633.5 billion KRW, recording a growth rate of 21% compared to the previous year. This is the highest growth rate among chronic disease treatments.

A JW Pharmaceutical official said, “As the market for dyslipidemia treatments continues to grow steadily, we plan to target the related market by launching new combination drugs. Rivarozet will be a good option for patients who require strong therapeutic effects but have difficulty with high-dose statin administration.”

This content was produced with the assistance of AI translation services.