SB Fails To Get CHF Backing For Carvedilol

SmithKline Beecham has failed to get backing from a US Food and Drug Administration advisory panel in its bid to extend the indications of Coreg (carvedilol) to include congestive heart failure. The drug has already been approved for hypertension in the USA, but SB and marketing partner Boehringer Mannheim have delayed launching the drug pending the review for the heart failure indication.

The Cardiovascular and Renal Drugs Advisory Committee voted 4-2 against recommending carvedilol for CHF, noting that there was a lack of confirmatory evidence to support the one US trial showing a reduction in progression to heart failure. SB was proposing an indication for "treatment of CHF patients who remain symptomatic while receiving conventional therapy, including ACE inhibitors. In these patients, carvedilol is indicated: to improve symptoms, well-being and overall clinical state, and to reduce morbidity and mortality."

The primary focus of the advisory committee meeting was on the multicenter study of carvedilol, which attracted so much coverage at last year's American Heart Association meeting (for overall results of this study, see Marketletter November 20, 1995).