This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryAmendment to the nesiritide NDA is expected to be filed by year's end, according to the firm. In January 1999, FDA's Cardio-Renal Drugs Advisory Committee recommended Natrecor for approval in treating chronic decompensated congestive heart failure, but FDA found the agent "not approvable" in April 1999, saying that further study was needed to "define the consequences of the pharmacodynamic profile." Enrollment has now been completed for the final Phase III, pivotal trial. The 490-patient study, known as the Vasodilation in the Management of Acute Congestive heart failure (VMAC) trial, was designed to "further evaluate the efficacy and safety of Natrecor in acutely ill patients with shortness of breath (dyspnea) at rest due to decompensated CHF," Scios said. An initial analysis of the study is expected to be released in the fal
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