JW Pharmaceutical has begun marketing Livalozet, the first domestic combination drug of pitavastatin and ezetimibe, for treating dyslipidemia.
The company said its dyslipidemia therapy doses are available in 2 or 4 milligrams of pitavastatin with 10 mg of ezetimibe. Medical professionals and patients should use the product for primary hypercholesterolemia and mixed dyslipidemia and administer it once a day regardless of fasted or fed state, it added.
In Korea, combination drugs of rosuvastatin, atorvastatin, and simvastatin with ezetimibe have been available in the market, but Livalozet is the first new drug that combined pitavastatin and ezetimibe.
Compared to high-dose statin monotherapy, the combination of statins and ezetimibe has an excellent effect in lowering low-density lipoprotein cholesterol (LDL-C) with reduced side effects, including muscle pain, decreased liver function, and diabetes risk, the company said.
The Ministry of Food and Drug Safety has recognized Livalozet for its improved safety, efficacy, and usefulness compared to existing drugs.
JW Pharmaceutical has conducted phase 3 clinical trials of Livalozet with 283 primary hypercholesterolemia patients at 25 hospitals since 2019.
The drug showed a 54 percent reduction in LDL-C safely without affecting blood sugar increase at the eighth week of administration. In other lipid indicators, Livalozet also showed superior effect compared to monotherapy.
Pitavastatin, an active ingredient of Livalozet and branded as Livalo by JW Pharmaceutical, also prevents cardiovascular diseases and safely controls the rise of blood glucose levels caused by statin-based drugs.
Livalo’s summary of product characteristics (SmPC) indicates that the drug has no risk of diabetes, which is unique among existing statin drugs, in 32 countries.
“Livalozet is a treatment that can reduce LDL-C by more than 50 percent in dyslipidemia patients and prevent cardiovascular disease,” a JW Pharmaceutical official said. “With the recent launch of Livalozet, our dyslipidemia treatment lineup based on Livalo will be an option that minimizes the side effects of elevated blood sugar for most patients.”
The domestic prescription of combination drugs for dyslipidemia totaled 633.5 billion won ($538 million) last year, up 21 percent from 2019. The prescription of Livalo amounted to 73.4 billion won in 2020, according to the company.