Scios Natrecor Outcomes Study Is Expected To Begin Enrollment In 2007
This article was originally published in The Pink Sheet Daily
Executive Summary
The Johnson & Johnson subsidiary will begin enrollment more than a year after an independent panel recommended the study.
|
Scios expects to begin enrollment for a large outcomes study to evaluate the safety profile of its congestive heart failure therapy Natrecor (nesiritide) in the first quarter of 2007, the Johnson & Johnson subsidiary announced June 1. An independent panel of cardiologists convened to assess clinical data on Natrecor recommended a year ago that Scios initiate the large outcomes trials "without delay" (1 (Also see "Natrecor Use Should Be Limited, Independent Panel Convened By J&J Says" - Pink Sheet, 14 Jun, 2005.)). The international, multi-center trial will enroll up to 7,000 acutely decompensated heart failure patients to evaluate improvement in dyspnea, rehospitalization, mortality, renal effects, quality of life and pharmacoeconomics. Although Scios has not estimated the duration of the study, the firm told "The Pink Sheet" DAILY that the trial design will likely include an interim analysis of 4,000 patients. Scios is currently looking for an independent academic research organization to oversee and execute the trial; a decision is expected "in the coming months." The trial is estimated to cost upwards of $100 mil. The firm maintained that it is too early to discuss specifics of the outcomes study and that the independent research organization will have substantial latitude when overseeing it. The 2005 independent panel provided specific recommendations for how the outcomes trial should be carried out. For example, the panel suggested that the trial "be adequately powered to detect an approximate 15% reduction in the combined risk of mortality and cardiorenal morbidities at an early time point, e.g. 30-90 days, and mortality at a later time point, e.g. 180 days." Natrecor's labeling was revised in April 2005 to include an expanded analysis of the mortality rates, including logarithmic plottings of the hazard ratio for 30-day mortality rates seen in all seven pivotal studies reviewed by FDA (2 (Also see "J&J/Scios Natrecor Labeling Change Includes Expanded Mortality Analysis" - Pink Sheet, 21 Apr, 2005.)). -Kathryn Phelps |