Pravachol Label Change Reveals MI Benefit

Bristol-Myers Squibb has been granted approval for a labeling change for its lipid-lowering drug Pravachol (pravastatin) in the USA, which draws attention to the fact that treatment with the HMG-CoA reductase inhibitor can reduce the rate of myocardial infarctions in patients with coronary disease by 67%. The product is the only one of its type to carry such labeling in the USA.

The supplemental New Drug Application was based on the results of the PLAC I and PLAC II (Marketletters passim), and the change has been made in the "clinical pharmacology" section of the labeling. The Food and Drug Administration is also reviewing data from two other trials, REGRESS and KAPS, intended to support a change to the "indications" section.

The change is an asset for Pravachol in the battle for supremacy in the anticholesterol drugs market. The current market leader, Merck & Co's Mevacor (lovastatin), does not carry this labeling but is the only drug of this type yet to be approved for slowing the progression of atherosclerosis.