BioCentury
ARTICLE | Regulation

Scios' Natrecor clears cardio panel

February 1, 1999 8:00 AM UTC

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...