Kowa successfully completes EU regulatory application for pitavastatin

Japan-headquartered drugmaker Kowa said yesterday that, following the completion of the decentralized regulatory procedure, its statin drug pitavastatin has achieved a positive outcome from the UK Regulatory Authority (MHRA) acting as the Reference Member State for 16 European Union countries.

Marketed as Livalo, the drug was launched last month in the USA by partner Eli Lilly, following US Food and Drug Administration approval in August 2009 (The Pharma Letter June 23), but is viewed as a late entrant into the huge, but now confronting generic competition, market for cholesterol lowerers.

Pitavastatin is indicated for the reduction of elevated total cholesterol (TC) and low density lipoprotein cholesterol (LDL-C), in adult patients with primary hypercholesterolemia, including heterozygous familial hypercholesterolemia, and combined (mixed) dyslipidemia, when response to diet and other non-pharmacological measures are inadequate.