In 1999, the FDA turned down Scios Inc.'s NDA for Natrecor nesiritide, even though the product met its efficacy end point of reduction in pulmonary capillary wedge pressure (PCWP) in congestive heart failure. With data now in hand from its Phase III VMAC study of Natrecor to treat acute decompensated CHF, SCIO believes it will be able to address the issues brought up by the FDA and the agency's Cardiovascular and Renal Drugs Advisory Committee.

Natrecor is a recombinant form of the human b-type natriuretic peptide (BNP) hormone that is produced by the human ventricle in response to heart failure. Although the product did receive a positive (5-3