JW Jungwoo Pharmaceutical obtains product approval for hyperlipidemia combination drug 'Rivarozet'... Launching in November

Pitavastatin and Ezetimibe Combination Dual Drug
Strengthening Pitavastatin-Based Dyslipidemia Treatment Lineup

[Asia Economy Reporter Kim Ji-hee] JW Pharmaceutical's combination drug based on pitavastatin, 'Rivarozet,' has received product approval.

JW Pharmaceutical announced on the 30th that it received approval from the Ministry of Food and Drug Safety for two products of Rivarozet tablets, 2/10 mg and 4/10 mg. Rivarozet is a two-drug combination drug that combines pitavastatin and ezetimibe, two components used to treat dyslipidemia (hyperlipidemia). It is used for primary hypercholesterolemia and mixed dyslipidemia.

Currently, combination drugs combining rosuvastatin, atorvastatin, and simvastatin with ezetimibe are marketed globally, including in Korea, but this is the first development of a combination drug of pitavastatin and ezetimibe. According to the company, statin and ezetimibe combination drugs have excellent effects in lowering low-density lipoprotein cholesterol (LDL-C) while reducing the risk of side effects such as muscle pain, liver function decline, and diabetes onset compared to high-dose statin monotherapy.

The main ingredient of Rivarozet, pitavastatin (product name Rivaro), is characterized by not only cardiovascular disease prevention effects but also safety related to diabetes. In 31 countries overseas, the drug information leaflet for Rivaro can include the phrase 'No signs of diabetes risk.' This is unique among statins.

Since 2019, JW Pharmaceutical has conducted a phase 3 clinical trial of Rivarozet on 283 patients with primary hypercholesterolemia at 25 hospitals nationwide, including Gangdong Sacred Heart Hospital. As a result, about a 53% reduction in LDL cholesterol was observed at 8 weeks after administration of Rivarozet. It showed superior effects compared to monotherapy in other auxiliary lipid indicators such as total cholesterol levels and very low-density lipoprotein cholesterol. There was no significant difference in safety indicators compared to monotherapy.

JW Pharmaceutical plans to launch the product in November this year after going through the insurance price listing process for Rivarozet. The company intends to strengthen its lineup of dyslipidemia treatments based on Rivaro. Previously, Rivarov (pitavastatin·valsartan) was launched in 2015, and besides Rivarozet, which received product approval this time, a three-drug combination drug is scheduled to enter phase 3 clinical trials within the year.

A JW Pharmaceutical official said, “Rivaro is recognized worldwide not only for its excellent lipid improvement and cardiovascular disease prevention effects but also for its safety regarding diabetes,” adding, “Rivarozet will be a good option for patients who require strong therapeutic effects but have difficulty with high-dose statin administration.”