Using Natrecor

BETHESDA, Md. - Scios Inc. made good on its second trip through the FDA's Cardiovascular and Renal Drugs Advisory Committee on Friday, rectifying the panel's former ambivalence about the effectiveness of Natrecor nesiritide and turning its attention to how the product would fit into clinical practice in terms of dose and management of side effects in the treatment of acute congestive heart failure (CHF).

In 1999, the committee cleared the compound by a 5-3 vote in what chairman Milton Packer said was "an extremely close call" (see BioCentury, Feb. 1, 1999).The FDA then issued a non-approvable letter, citing concerns raised by the panel about Natrecor's slow onset of action, potential to cause hypotension and lack of comparative safety data against existing treatments, such as nitroglycerin. ...