Atorvastatin: 1st Approvals In UK And Germany

Warner-Lambert has been granted the first world approvals for atorvastatin, its new HMG-CoA reductase inhibitor for lipid-lowering treatment, in the UK and Germany. The drug will be marketed in the UK as Lipitor and as Sortis in Germany.

The company submitted a New Drug Application in the USA in June, and regulatory submissions have also been filed in 20 other countries. A spokesman for the firm said that owing to the sensitive and competitive nature of the HMG-CoA reductase sector, W-L was unable to comment on the scheduling of launches in these countries.

Atorvastatin has a profile which W-L believes distinguishes it from its competitors, ie Merck & Co's Zocor (simvastatin) and Mevacor (lovastatin), Bristol-Myers Squibb's Pravachol (pravastatin) and Sandoz' Lescol (fluvastatin). Recently long-term studies such as the 4S, CARE and WOSCOPS trials (Marketletters passim) have shown a clear reduction of cardiovascular mortality in patients treated with statins as a method of primary and secondary prevention.