Input 2021.03.22 09:20
JW Pharmaceutical announced on the 22nd that’Libarojet’, which is being developed as a complex new drug for dyslipidemia (hyperlipidemia), has completed phase 3 clinical trials in Korea and has applied for product approval.
Lavarozet is a two-drug combination drug that combines phytavastatin and ezetimibe, two ingredients that treat dyslipidemia.
In the global market, a combination drug in which atorvastatin and rosuvastatin are combined with ezetimibe are on the market, respectively, but this is the first time that a combination drug of phytavastatin and ezetimibe ingredients has been developed.
Pitavastatin, which is the basis of a new combination drug, has not only preventive effects on cardiovascular diseases, but also has diabetes-related safety. In 31 foreign countries, the phrase’no signs of diabetes risk’ can be inserted in the drug manual of Rivaro, which is the only statin family.
Since 2019, JW Pharmaceutical has conducted a phase 3 clinical trial of ribarojet on 283 patients with primary hypercholesterolemia in 25 hospitals nationwide including Gangdong Sacred Heart Hospital.
The clinical phase 3 administration group was divided into a single drug ribaro (pitavastatin) group and a combination drug ribarojet (pitavastatin ezetimibe) group, and the rate of change in LDL cholesterol level was observed after 8 weeks. As a result of the clinical results, at 8 weeks after administration, the Rivaro-administered group showed an effect of reducing LDL cholesterol by about 37% and the ribarojet-administered group by about 53%, according to the company.
In other supplementary lipid indicators such as total cholesterol (TC) and non-HDL cholesterol (Non-HDL-C), including HDL (ultra-low-density lipoprotein cholesterol), ribarojet showed superior effects compared to single drugs. It was confirmed that the degree of improvement was high.
JW Pharmaceutical plans to strengthen its lineup of cardiovascular and metabolic disease treatments based on Rivaro. Rivarovi (Pitavastatin, Valsartan) was launched in 2015, and in addition to Rivarojet, which applied for this item license, a three-drug combination drug is expected to enter clinical trials this year.
According to Ubist, a drug research organization, the prescription amount for the lipid-regulator combination drug last year recorded 6335 billion won, a 21% growth rate compared to the previous year. This is the highest growth rate among chronic disease treatments.
An official of JW Pharmaceutical said, “With the dyslipidemia treatment market growing steadily, we plan to target the related market by launching a new combination drug.” “It will be a good option for patients.”