Global’s first phytavastatin-ezetimibe combination drug… Targeting the cardiovascular disease complex market
Excellent LDL cholesterol reduction effect compared to single drug
Expect new treatment for patients with high-dose statin therapy
[팜뉴스=이권구 기자] JW Pharmaceutical is strengthening its lineup of new complex drugs based on pitavastatin and actively targeting the rapidly growing market for combination drugs 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 in which atorvastatin and rosuvastatin are combined with ezetimibe are marketed, respectively, but this is the first time that a combination drug with pitavastatin and ezetimibe ingredients has been developed.
Pitavastatin (product name Rivaro), which is the basis of a combination new drug, has not only preventive effects on cardiovascular diseases, but also has diabetes-related safety. In 31 overseas countries, the phrase “no diabetic risk sign” can be inserted in the “Rivaro” 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 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 ribaro-administered group showed about 37% LDL cholesterol reduction effect, and the ribarojet-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. 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.”
Meanwhile, according to Ubist, a drug research organization, the amount of prescriptions for lipid-regulator complexes last year was 6335 billion won, an increase of 21% from the previous year. This is the highest growth rate among chronic disease treatments.
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