JW Choongwae Pharm, applied for product approval of’Rivarojet’, a new complex drug for hyperlipidemia
Proven better effect than single drug in domestic phase 3 clinical trial
(Seoul = Yonhap News) Reporter Seung-Hyun Gye = JW Pharmaceutical announced on the 22nd that it has applied for a product license after completing a phase 3 clinical trial in Korea for’Libarojet’, which is being developed as a complex new drug for hyperlipidemia.
Rivarozet is a two-drug combination drug that combines phytavastatin and ezetimibe, two ingredients that treat hyperlipidemia.
Pitavastatin (product name Livaro) has the effect of preventing cardiovascular disease and safety related to diabetes. In 31 countries abroad, Rivaro’s drug manual can include the phrase’no signs of diabetes risk’.
Since 2019, JW Pharmaceutical has conducted a phase 3 clinical trial of ribarojet on 283 patients with primary hypercholesterolemia at 25 hospitals nationwide, including Gangdong Sacred Heart Hospital.
In clinical practice, the administration group was divided into a single drug ribaro (pitavastatin) group and a combined drug ribarojet (pitavastatin ezetimibe) group, and after 8 weeks, the rate of change in low-density lipoprotein cholesterol (LDL), called’bad cholesterol’, was tracked. Observed.
As a result, the LDL reduction rate at 8 weeks after administration was about 37% in the ribaro administration group and about 53% in the ribarojet administration group.
In other supplementary lipid indicators, such as total cholesterol (TC) and ultra-low-density lipoprotein cholesterol (HDL), ribarojet showed better effects than a single drug, confirming that the combination therapy had a higher improvement in treatment compared to the monotherapy. There was no significant difference from the single drug in terms of safety including adverse reactions.
JW Pharmaceutical plans to strengthen its lineup of cardiovascular and metabolic disease treatments based on Rivaro. In 2015, it launched’Rivarovi’ (Pitavastatin, Valsartan), and in addition to the Rivarojet, which applied for this item permission, it is planning to enter the clinical trials of a three-drug new drug this year.
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