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Revamped approach improves Natrecor outcome
Monday, November 20, 2000
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
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