Scios Natrecor

Executive Summary

Nesiritide is not approvable for treatment of acute episodes of congestive heart failure, FDA tells company April 27. "The agency determined that further study is needed to define the consequences of the pharmacodynamic profile, specifically as it relates to the onset of effect and the recovery from hypotension if it occurs," the company said. Scios noted that "FDA acknowledged that Natrecor reduced pulmonary capillary wedge pressure, increased cardiac output, and produced some evidence of symptomatic benefit." The product was recommended for approval in treating chronic decompensated CHF by FDA's Cardio-Renal Drugs Advisory Committee in January ("The Pink Sheet" Feb. 1, p. 5)