FDA Approves Acute Congestive Heart Failure Treatment

The Food and Drug Administration (FDA) has approved Natrecor® (nesiritide) Injection for the treatment of acute congestive heart failure (CHF).

Natrecor® is a synthetic version of a human hormone that dilates veins and arteries. Natrecor® is manufactured using recombinant DNA technology by Scios, Inc., of Sunnyvale, Calif.

FDA based its approval on scientific data from a number of controlled clinical trials in people with acute CHF, including the recent Vasodilatation in the Management of Acute Congestive Heart Failure Trial (the VMAC study).

The VMAC study involved a total of 489 patients who required hospitalization for the management of shortness of breath at rest due to CHF. VMAC participants were randomized and treated with Natrecor®, intravenous nitroglycerin or placebo (for 3 hours).

In the VMAC study, patients receiving Natrecor® reported greater improvement in shortness of breath than patients receiving placebo.

The major adverse reaction associated with Natrecor® is low blood pressure (i.e., hypotension). Higher than the recommended doses of Natrecor® caused significantly more, and more prolonged hypotension, than standard CHF therapy. The lower doses, administered in the VMAC study, caused hypotension at about the same rate as nitroglycerin, although the hypotension was more prolonged.

This week's approval follows the May 25, 2001 and January 29, 1999 recommendations made by FDA's Cardiovascular and Renal Drugs Advisory Committee.