JW Pharmaceutical said on Friday that the Department of Food and Pharmaceutical Safety had approved two products Livalozet – 2/10 mg and 4/10 mg – combination drugs made with pitavastatin for dyslipidemia.
The ministry based its approval on the phase 3 clinical trial of Livarozet in 25 hospitals, including the Sacred Heart Hospital in Gangdong, targeting 283 patients with primary hypercholesterolemia.
Clinical results showed a lowering effect of low density lipoprotein (LDL) cholesterol by approximately 53 percent at the eighth week after administration of Livarozet and showed superior effects compared to a single drug in other auxiliary lipid indicators such as total cholesterol (TC) -density lipoprotein cholesterol (HDL). There was also no significant difference with a single agent in the safety index.
“The Ministry of Food and Pharmaceutical Safety has approved the first approval of a pitavastatin-based combination drug for dyslipidemia in Korea,” the company said. “We plan to actively target the rapidly growing market for statin and ezetimibe combinations with approval. “
Although rosuvastatin, atorvastatin and simvastatin combined with ezetimibe are commercially available worldwide, including in Korea, this is the first time that a Korean company has developed a new drug combining pitavastatin and ezetimibe. , he added.
According to JW, the combination of statin and ezetimibe has an excellent effect on lowering low protein cholesterol (LDL-C) and reduces the risk of side effects such as muscle pain, decreased liver function. and the risk of diabetes, compared to a high-dose statin monotherapy.
“Pitavastatin, the main ingredient in Livarozet, has not only helped prevent cardiovascular disease, but has also confirmed the safety of treating diabetic patients,” the company said. “Livalo is the only statin drug that can insert the phrase ‘no signs of risk of diabetes’ in its summary of product characteristics in 31 countries.”
JW Pharmaceutical plans to introduce the product from November after going through the reimbursement registration process for Livarozet.
It also plans to strengthen its line of dyslipidemia treatments based on Livalo. With the addition of Livalozet, the company now has three products in its range, including Livalo and Livalo V.
The company also plans to enter Phase 3 clinical trials of a three-agent combination drug this year.
“Livaro has been recognized around the world for its excellent effects in improving lipids and preventing cardiovascular disease, as well as for its safety against diabetes,” said a company official. “For patients who require a strong therapeutic effect and high-dose statins that are difficult to administer, Livarozet will be a good option. “
Livalozet is a two-agent combination medicine that combines two components – pitavastatin and ezetimibe – to treat dyslipidemia (hyperlipidemia), primary hypercholesterolemia and mixed dyslipidemia. Patients can take the drug once a day, regardless of meals.
