J&J's Natrecor Doesn't Meet Endpoint in CDHF Study

Scios, a wholly owned subsidiary of Johnson & Johnson (J&J), announced that an exploratory 920-patient, Phase II study of Natrecor (nesiritide) showed a neutral effect on the primary endpoint, a composite of death and cardiorenal hospitalization at 12 weeks, but provides important renal and mortality safety data on Natrecor in patients with advanced chronic decompensated heart failure (CDHF) receiving serial outpatient infusions.

Currently Natrecor is approved as a treatment for patients with acutely decompensated congestive heart failure who have dyspnea (shortness of breath) at rest or with minimal activity.

Data from the CDHF study, known as FUSION II, was presented at the American College of Cardiology's 56th Annual Scientific Session in New Orleans. Scios said it plans to submit the safety data from trial to the FDA.

FUSION II was designed to assess the long-term safety and outcomes at six months of once- or twice-weekly infusions of Natrecor compared with placebo in persistently symptomatic CDHF patients. All patients received ongoing intensive heart failure disease management, including optimization of standard heart failure medications and once- or twice-weekly outpatient clinic visits.

The study demonstrated comparable renal and mortality effects in both study arms. In addition, there was no statistically significant difference in the primary endpoint between patients receiving Natrecor compared with patients receiving placebo infusions when each was added to optimal heart failure medications, significant use of indicated heart failure devices and intensive disease management.