- Drugmaker’s phase 1 clinical trial on dyslipidemia treatment approved
JW Pharmaceuticals has begun to develop a drug which combines two dyslipidemia treating tablets -- Livaro (Pitavastatin) and Ezetimibe.
The Ministry of Food and Drug Safety approved on Monday the phase 1 clinical trial to evaluate the safety and pharmacokinetic properties of the combined use of Livaro(4mg) and Ezetrol(10mg). This clinical trial will be conducted for healthy male volunteers at the Catholic University’s Seoul St. Mary’s Hospital.
Livaro is a dyslipidemia treatment launched by JW Pharmaceuticals in Korea in 2014.
Notably, the “PROPIT” research conducted for 48 weeks on 164 Koreans with the metabolic syndrome proved the effects of Livaro; among the patients who took the tablet, 65 percent showed lower cholesterol, and 44 percent was excluded from the metabolic syndrome patient category.
The risk of cardiovascular diseases also fell for those who took Livaro, as the obesity rate and the risk of coronary diseases decreased along with the blood lipid levels. The dropped obesity rates of the participating patients were confirmed through abdominal CT.
This research result drew attention as it came out right after another report showing statin-based drugs induce diabetes, indicating that taking Livaro does not increase the blood glucose level but slightly improves it.
JW Pharmaceutical also induced the prescription of the medicine by emphasizing that it can help relieve anxiety on diabetes while improving dyslipidemia. The drugmaker further boosted its market share by launching Livaro V which also combined the hypertension treatment valsartan.
The outpatient prescriptions of Livaro stood at 51.1 billion won ($45.4 million), and that of Livaro V was 7.3 billion won in 2017, according to market research company UBIST.