The study compares Natrecor with placebo in order to gauge the risk profile of the drug. The new findings may exacerbate recent safety concerns around the drug, which was approved for the treatment of acute heart failure in 2001.
The company will now re-analyze the data in light of the new findings to see if the difference now reaches statistical significance, however the company said in a statement that it is “confident these two additional cases have no impact on the overall benefit/risk profile of Natrecor when prescribed according to the approved label.”
In January 2005, Scios agreed with the FDA to conduct an expanded analysis to evaluate all-cause mortality through 180 days following treatment with Natrecor or placebo. This expanded analysis goes beyond the study’s original protocol defined 30-day mortality follow-up period.
It was in the course of conducting this expanded analysis that the two additional deaths at 30 days post treatment were identified. A final report of this expanded analysis is planned for submission to FDA, as well as to relevant health authorities in other countries, in the first quarter of 2006.