Johnson & Johnson’s heart failure drug Natrecor (nesiritide) has a new label, after the US Food and Drug Administration agreed to include mortality data from a range of comparative clinical trials. The move follows questions raised amongst the medical community, and published in the prestigious Journal of the American Medical Association, that it may be linked to an increased risk of death.
The article, in the latest issue of JAMA, was a pooled analysis of randomized clinical trials of Natrecor, and found an increased risk of death within 30 days of treatment with J&J’s drug. The authors recommended that this finding be investigated in a large-scale controlled trial before routine use of nesiritide for acutely decompensated heart failure could be recommended.
The publication triggered, Scios – a unit of J&J – to convene an expert panel to review the product’s clinical trials and to provide guidance for future clinical development. Eugene Braunwald, Professor of Medicine at Harvard Medical School, who will chair the panel, commented: “A recent publication has raised questions about its safety and the potential need for additional data to ensure the appropriate use of Natrecor. The panel I will convene will examine all of the existing data and the planned clinical development program to assess the questions raised and to make recommendations to the manufacturer.”
- Meanwhile, J&J – which bought Scios in 2003 for $2.4 billion [[11/02/03e]] – says the European Commission has entered into the second stage of review in its $25 billion purchase of Guidant Corporation [[16/12/04a]]. The Commission has 90 days to issue its opinion and the companies now expect to close the deal in the third quarter.