Bayer's Lipobay Cleared In The UK, Its First Market

Bayer AG has been granted approval in the UK to market its HMG-CoAreductase inhibitor Lipobay (cerivastatin) for the treatment of patients with primary hypercholesterolemia who have not responded adequately to dietary restriction. This is the first approval to market the product worldwide, according to the company.

Clinical trials with cerivastatin have shown that once-daily dosing of just 100mcg to 300mcg can achieve up to a 30% reduction in LDL cholesterol - a reduction which would require doses 50 to 100-times higher with certain other drugs in this class, according to a report in the British Journal of Cardiology (March). Unlike some other statins, cerivastatin has no drug interactions with warfarin and digoxin.

Launch plans and pricing were not available by the time this on-line edition of Marketletter went to press, but more details should be available in our updated filing (dated March 17). Bayer reportedly said that Lipobay will be "competitively priced" with other statins.