The first European launch of statin, pitavastatin, in Spain has been welcomed by Kowa Pharmaceutical Europe. It will be marketed and distributed as Livazo® by Recordati, and as Alipzadegrees by Recordati’s partner distributor, Esteve.
Spain is the first European market for Livazo, which is indicated for patients with primary hypercholesterolemia and / or mixed dyslipidemia. Kowa Pharmaceutical Europe Co. Ltd., with Recordati, intends to launch Livazo in further European markets later this year and into 2012.
Livazo is a potent statin that combines effective control of low density lipoprotein-cholesterol (LDL-C) and triglycerides (TG), with long-term incremental high density lipoprotein-cholesterol (HDL-C) increase and, due to its novel structure, is less likely to have drug-to-drug interactions. Its effectiveness has been demonstrated in several Phase III clinical studies:
- Livazo safely and effectively reduced LDL-C and achieved European Atherosclerosis Society (EAS) guideline targets in the majority of patients with primary hypercholesterolemia or mixed dyslipidemia, similar to reductions seen with atorvastatin and simvastatin
- Livazo 2mg and 4mg demonstrated comparable efficacy to commonly prescribed statins, with 2mg Livazo demonstrating statistically significant superior efficacy compared with simvastatin 20mg in lowering LDL-C, non high-density lipoprotein cholesterol (non-HDL-C) and total cholesterol (TC)
- Livazo effectively reduced LDL-C in the elderly and also improved LDL-C and other parameters of lipid metabolism in patients at higher cardiovascular risk
- Livazo was superior to pravastatin in improving LDL-C in elderly patients (aged 65 years and older)
- Livazo demonstrated a gradual and sustained increase in HDL-C over the long-term, supported by data from a 52 week extension study.
“Pitavastatin is an attractive treatment option for clinically complex patients in Europe on multiple medications, due to its distinct pharmacological characteristics, among which the low drug-drug interaction seen in clinical trials is particularly relevant. It has also shown strong efficacy in metabolic syndrome patients without effect on HbA1C levels, as well as in elderly patients,” said Professor John Chapman, Director, Dyslipidemia and Atherosclerosis Research Unit, National Institute of Health and Medical Research, Hôpital de la Pitié-Salpêtrière Université Pierre et Marie Curie Paris, France.
“Innovative treatments such as Livazo are key to advancing disease management as it has shown this innovative statin not only lowers LDL-C effectively but also addresses low residual risk, meaning associated with low HDL-C, clearly suggesting that it has the potential to increase the proportion of patients achieving treatment targets,” added Prof Chapman.
High cholesterol levels are a major risk factor for heart disease (cardiovascular disease), the number one cause of death globally and accounts for 33% of all deaths in Spain.
The overall safety and tolerability of pitavastatin are consistent with other commonly prescribed statins. In Phase III studies comparing pitavastatin with atorvastatin, simvastatin and pravastatin, the overall safety profile of pitavastatin was demonstrated, with low incidences of adverse events. All three doses of pitavastatin (1, 2 and 4mg) demonstrated a comparable safety profile to 10, 20 and 40mg of pravastatin, which is considered to be the statin least likely to cause adverse drug reactions or drug -drug interactions. Additionally, pitavastatin has demonstrated a long-term safety profile (to 52 weeks), comparable to that of simvastatin or atorvastatin.
Drummond Paris, President of Kowa Research Europe, said: “The launch of Livazo in Spain represents a great milestone for Kowa as our first European launch. It will be the first of many launches in Europe, the Middle East and North Africa during 2011. We are keen to offer patients across the globe improved treatment choice and access to Livazo.”