Johnson & Johnson’s heart failure drug Natrecor (nesiritide) should be limited to use on only the sickest patients until new clinical trials can prove the drug’s safety, according to an advisory panel convened by the drug giant.
The committee, headed by eminent cardiologist Eugene Braunwald of Harvard Medical School in Boston, USA, was assembled to decide once and for all how Natrecor should be used clinically after safety concerns emerged with the drug earlier this year [[20/04/05b]]. In April, the US Food and Drug Administration and J&J agreed to tighten the drug’s labelling on the back of a meta-analysis in the Journal of the American Medical Association, which suggested that it was associated with a raised risk of kidney damage and death when added to standard heart failure treatment regimens [[26/04/05b]].
After reviewing the clinical data, the panel has recommended that Natrecor should be reserved for use in acutely ill, hospitalised patients who have difficulties breathing even at rest, while J&J conducts a large-scale study to prove the drug is safe.
The cardiologists concluded that Natrecor was associated with a dose-dependent increase in serum creatinine, a marker of kidney disease, although the clinical consequences of this were not clear. They also agreed that the available data clearly showed a 30% increase in mortality 30 days after the onset of treatment, although statistically this was hard to establish with certainty. The panel also recommended that a trial involving several thousands of patients should be undertaken to “assess further the benefits and risks of [Natrecor] compared to standard therapy”. Scios and J&J said this trial is already at the planning stage.
J&J acquired Natrecor as part of its $2.4 billion dollar purchase of Scios in 2003 [[11/02/03e]], and the drug had US sales of $390 million last year, according to NDCHealth.