[FETV=김창수 기자] JW Pharmaceutical is strengthening its lineup of pitavastatin-based complex new drugs and actively targeting the fast-growing combination drug market for cardiovascular diseases.
JW Pharmaceutical announced on the 22nd that’Libarojet’, which is being developed as a complex new drug for dyslipidemia, has completed phase 3 clinical trials in Korea and applied for an item license.
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 of atorvastatin and rosuvastatin combined with ezetimibe is being marketed, respectively, but this is the first time that a combination drug of pitavastatin 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 combination 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.
In other supplementary lipid indicators such as total cholesterol (TC) and non-HDL cholesterol (Non-HDL-C), including HDL (extremely low-density lipoprotein cholesterol), ribarojet showed superior effects compared to single drugs, so combination therapy was treated compared to monotherapy. It was confirmed that the degree of improvement was high. 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, and in addition to Rivarojet, which applied for this item license, a three-drug combination drug 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.”
Meanwhile, according to Ubist, a drug research institute, the prescription amount for the lipid-regulator combination drug last year recorded 6335 billion won, a growth rate of 21% compared to the previous year. This is the highest growth rate among chronic disease treatments.