[서울=뉴스핌] Reporter Jeong Seung-won = JW Pharmaceutical is strengthening its line-up of pitavastatin-based complex new drugs to target the cardiovascular disease complex market.
JW Pharmaceutical announced on the 22nd that it has completed phase 3 clinical trials in Korea and applied for an item permission from the Ministry of Food and Drug Safety for’Libarojet’, which is being developed as a complex new drug for dyslipidemia.
 |
| JW Pharmaceutical logo [사진= JW중외제약] |
Lavarozet is a two-drug combination drug that combines pitavastatin and ezetimibe, two ingredients that treat dyslipidemia (hyperlipidemia).
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 (product name Rivaro), 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 overseas countries, the phrase’no signs of diabetes risk’ can be inserted in Rivaro’s Drug Manual (SmPC), 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 phase 3 administration group was divided into a single drug ribaro (pitavastatin) group and a combined drug ribarojet (pitavastatin + ezetimibe) group, and the rate of change in LDL cholesterol level was observed after 8 weeks.
Clinical results 8 weeks after administration, the Rivaro-administered group showed about 37% LDL cholesterol reduction effect, and the Rivaro-Jet-administered group showed about 53% reduction in LDL cholesterol.
Rivarozet showed superior effects compared to single drugs in other supplementary lipid indicators such as total cholesterol (TC) and non-HDL cholesterol (Non-HDL-C) including HDL (ultra-low density lipoprotein cholesterol). It was confirmed that the degree of improvement in treatment was higher than that.
In terms of safety including adverse reactions, there was no significant difference from the single drug.
JW Pharmaceutical is planning to strengthen its lineup of cardiovascular and metabolic disease treatments based on Rivaro (Pitavastatin).
Rivarovi (Pitavastatin, Valsartan) was launched in 2015. In addition to the Rivarojet, which applied for this product license, a combination of three new drugs is expected to enter clinical trials this year.
An official from JW Pharmaceutical said, “With the dyslipidemia treatment market growing steadily, we plan to target the related market by launching a new combination of complex drugs.” “It will be a good option for patients in need.”