Analysts Cast Doubt On Kredex' Potential In USA

Although SmithKline Beecham's carvedilol has now been approved for thetreatment of heart failure in several countries, its progress in the biggest CHF market, the USA, has been hampered by the requirements of the Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee (Marketletter May 13, 1996).

Following the publication of new Phase III data on carvedilol's activity in CHF in The Lancet on February 7, analysts Mark Tracey and John Murphy at Goldman Sachs say they are becoming "increasingly cautious" regarding the outcome of the next FDA panel meeting for the drug, scheduled for February 27.

It was reported after the April 1996 panel meeting that SB had already submitted further data in support of the CHF indication. This data was from the newly-published study and, according to the analysts, does not go further than the data the panel reviewed in April in support of the application.