Carvedilol Backed For Heart Failure In USA

10 March 1997

Carvedilol has been recommended for approval as a treatment forcongestive heart failure by the US Food and Drug Administration's Cardiovascular and Renal Drugs Advisory Committee, putting to an end some uncertainty regarding the outcome of this second Committee hearing (Marketletter February 17).

Carvedilol, which is known by the trade name Coreg in the USA, has been developed by SmithKline Beecham and Boehringer Mannheim. It is already approved for CHF in a number of countries, including Canada, France, Spain, Sweden and Austria, and is widely approved for hypertension and angina. The drug is also registered for the treatment of hypertension in the USA, but there has been speculation that it would not be launched there, on commercial grounds, unless the CHF indication was granted.

Ostensibly a beta blocker, carvedilol has a range of other activities which support its use in CHF. It acts as a neurohormonal antagonist and has vasodilating and antioxidant properties, and represents a new approach in the treatment of CHF.

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