Revamped approach improves Natrecor outcome

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) recommendation from the panel, members expressed concern about the lack of data for the use of Natrecor in the presence of myocardial infarction (see BioCentury, Feb. 1, 1999).Committee members also noted that because BNP is an endogenous protein, physicians would not know the patient's baseline level of hormone prior to treatment. ...