Bayer's Baycol Cleared For US Marketing

Baycol (cerivastatin sodium), Bayer's new cholesterol-lowering drug, hasbeen approved for marketing in the USA by the Food and Drug Administration, with a launch expected first-quarter 1998. The drug is already sold in the UK (as Lipobay) and it is hoped that approval in several other major markets worldwide will be forthcoming later this year.

Bayer says it expects Baycol, an HMG-CoA reductase inhibitor or statin, to become an important option for patients with elevated cholesterol. The drug has shown efficacy at relatively low doses on low density lipoprotein-cholesterol as well as total cholesterol and triglycerides.

Clinical trials have shown shown that once-daily dosing of 0.2mg-0.3mg produces up to a 28% reduction in LDL-cholesterol, a 13% cut in triglycerides and a 10% increase in high density lipoprotein-cholesterol. Moreover, Bayer notes, studies have confirmed that Baycol has a favorable interaction profile with commonly-used drugs such as warfarin, digoxin, cimetidine and antacids.