Recordati and partner Kowa Co are celebrating the news that their cholesterol-lowerer pitavastatin has been given the green light in key European markets.

The Italian drugmaker has announced the positive outcome of the decentralised procedure for the approval of pitavastatin (to be sold as Livazo, Alipza and other brands)in Europe following a decision by the reference member state (the UK’s Medicines and Healthcare products Regulatory Agency) and the agreement of all the concerned member states. The drug is indicated for the reduction of elevated total cholesterol and LDL-C, in adults with primary hypercholesterolaemia and mixed dyslipidaemia “when response to diet and other non-pharmacological measures is inadequate”.

Recordati bagged pitavastatin rights for the majority of the European market from Kowa in October 2008. It has been available in Japan since 2003 and was launched last month in the USA by Kowa and co-promotion partner Eli Lilly.

The statin market is pretty crowded but Kowa, Recordati and Lilly have previously noted that pitavastatin offers a new option as it is only minimally metabolised by the liver through the cytochrome P450 pathway. This suggests that the potential for clinically significant drug interactions between the drug and treatments that inhibit or that are metabolised by CYP450 enzymes, including warfarin, would be reduced.

Recordati has yet to respond to an inquiry about timelines for launches in Europe.