JW Choongwae Pharmaceutical announced on the 30th that it had received product approval from the Ministry of Food and Drug Safety for two items, 2/10mg and 4/10mg of Rivarozet Tablet.
Rivarozet is a new combination drug combining two components, pitavastatin and ezetimibe, to treat dyslipidemia (hyperlipidemia). It is used for primary hypercholesterolemia and mixed dyslipidemia.
Currently, a combination drug combining rosuvastatin, atorvastatin, and simvastatin with ezetimibe is on the market in the global market, but this is the first time that a new combination drug of pitavastatin and ezetimibe has been developed.
The combination of statin and ezetimibe has an excellent effect in lowering low-protein cholesterol (LDL-C) while reducing the risk of side effects, such as muscle pain, decreased liver function, and the risk of diabetes, compared to high-dose statin monotherapy, the company explained.
Pitavastatin (product name: Rivaro), the main ingredient of Rivarozet, has not only a cardiovascular disease prevention effect but also diabetes-related safety. In 31 overseas countries, it is the only statin group that can insert the phrase ‘no diabetes risk’ in the drug label of Livaro.
Since 2019, JW Pharmaceutical has conducted a phase 3 clinical trial of Rivarozet in 25 hospitals nationwide, including Gangdong Sacred Heart Hospital, targeting 283 patients with primary hypercholesterolemia.
Clinical results showed that LDL cholesterol was reduced by about 53% at 8 weeks after administration of Rivarozet, and it showed superior effects compared to single agent in other auxiliary lipid indicators such as total cholesterol (TC) and ultra-low-density lipoprotein cholesterol (HDL). There was no significant difference with single agent in safety index.
JW Pharmaceutical plans to introduce the product in earnest in November this year after going through the insurance drug price registration process for Rivarozet. It also plans to strengthen its dyslipidemia treatment lineup based on Livaro (pitavastatin).
An official from JW Pharmaceutical said, “Rivaro has been recognized for its excellent lipid improvement and cardiovascular disease prevention effects, as well as for its diabetes safety. It will be a good option,” he said.
Reporter Lee Ha-rin, Global Economics email@example.com