Japan’s Kowa Co has received approval from US regulators for its cholesterol drug Livalo, which will be the latest statin to hit the market across the Atlantic.

Kowa’s US subsidiary announced that the Food and Drug Administration has approved Livalo (pitavastatin) for the primary treatment of hypercholesterolaemia and combined dyslipidaemia. The company noted that the treatment is expected to be launched in the first quarter of 2010 and will enter the “large, competitive market for cardiometabolic disorders”, occupied by Pfizer’s Lipitor (atorvastatin), AstraZeneca’s Crestor (rosuvastatin) and the generic version of Merck & Co’s Zocor (simvastatin), among many others.

Livalo was approved on the basis of five clinical trials comparing its efficacy and safety to that of three currently marketed statins, noted the FDA. The most frequently reported adverse reactions from taking the drug were muscle, back and joint pain, plus constipation.

Kowa is confident there is a place for Livolo, which is already on the market in Japan, South Korea, Thailand and China, “and has accumulated millions of patient-years of exposure”. It differs from other statins, the firm says, in that it “has a unique cyclopropyl group on the base structure”.

This contributes to a more effective inhibition of the HMG-CoA reductase enzyme to inhibit cholesterol production, and “potentially affords greater low-density lipoprotein cholesterol (LDL-C) clearance and reduction of plasma cholesterol”, Kowa claims. The company adds that “importantly, pitavastatin is only minimally metabolised by the liver through the cytochrome P450 pathway, through which many other medications are metabolised”.

Kowa cited Antonio Gotto of Cornell University in New York as saying that Livalo has a robust safety, efficacy and tolerability profile and “offers an attractive alternative”. He added that the drug has “very positive attributes” for “clinically complex patient populations, such as the elderly, patients with diabetes or patients who take multiple medications for co-morbid conditions".

Competition is indeed fierce though and Kowa says that following “a thorough review of the statin market”, it is seeking a co-promotion partner in order to broaden the reach of “rapidly-growing internal” sales force in the USA. Italy’s Recordati signed a deal for the rights to Livolo covering a number of European countries in October last year.