FDA Clears SB's Carvedilol For CHF

The US Food and Drug Administration has approved SmithKline Beecham'sCoreg (carvedilol) for the treatment of congestive heart failure, following a positive recommendation from an FDA advisory committee, which put an end to uncertainty over the drug's future (Marketletter March 10).

A beta blocker in the main, Coreg also acts as a neurohormonal antagonist and has vasodilating and antioxidant properties. This is the first drug of its class to be cleared for the CHF indication, and is the first new approach to the treatment of heart failure in the USA for 14 years, according to the company.

Coreg is indicated for "the treatment of mild-to-moderate heart failure of ischemic or cardiomyopathic origin, in conjunction with digitalis, diuretics and ACE inhibitors, to reduce the progression of disease as evidenced by cardiovascular death, cardiovascular hospitalization, or the need to adjust other heart failure medications," says SB. It may also be used in patients unable to tolerate an ACE inhibitor, and in patients not receiving digitalis, hydralazine or nitrate therapy.