Monday, February 1, 1999
BETHESDA, Md. - An FDA advisory committee on Friday voted 5
to 3 to recommend approval of Scios Inc.'s Natrecor nesiritide for short-term
treatment of decompensated congestive heart failure (CHF).
Although a majority of committee members voted in favor, most also expressed concern that it will be difficult to translate data from SCIO's clinical trials into good advice to physicians about the use of Natrecor. Panel members also worried about lack of data for use of the drug in the presence of heart attack, and said additional data should be collected after the drug is marketed about interactions with other heart drugs and about Natrecor's effects on kidney function.
If FDA agrees with the Cardiovascular and Renal Drugs Advisory Committee, Natrecor would be SCIO's first product approval since the company was formed in 1981 as California Biotechnology Inc. It also would be the first new intravenous vasodilator to reach the U.S. market in more than a decade.
CHF is a heart condition that results in poor pumping function and lower flow of blood throughout the body. It results in about 1 million U.S. hospitalizations annually, according to the company. SCIO President and CEO Richard Brewer told BioCentury that the 700,000 to 800,000 of these patients who are not in shock would be potential candidates for Natrecor.
Bayer AG has a worldwide license to market Natrecor (see BioCentury, June 8, 1998), a recombinant form of the human b-type natriuretic peptide (BNP) hormone, which is produced by the human ventricle in response to heart failure.