Kyowa’s cholesterol-lowering drug is already marketed in Japan and the U.S.
Recordati and Esteve inked a co-marketing agreement for the dyslipidemia drug pitavastatin in Spain. Recordati has a European license to the therapy from Kowa Pharmaceuticals.
Pitavastatin is an oral HMG-CoA reductase inhibitor. It is currently under review by U.K. regulatory authorities. Recordati says approval in the U.K. is expected during the second half of this year.
The drug has been marketed in Japan since 2003 and was granted FDA sanction in August 2009. Called Livalo® in the U.S., FDA approval covers use of pitavastatin for the primary treatment of hypercholesterolemia and combined dyslipidemia.