Natrecor Safety Labeling Change Likely, J&J Says
This article was originally published in The Pink Sheet Daily
Executive Summary
The company is in discussions with FDA to “ensure that correct conclusions are in label.” Adverse publicity from Circulation article questioning kidney safety of CHF drug is having an impact; mortality analysis in JAMA will raise more questions.
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Scios is in discussions with FDA about updating the safety labeling of Natrecor (nesiritide), Johnson & Johnson VP-Investor Relations Helen Short told an April 19 quarterly conference call. "We are...having some discussions with the FDA about the language in the label to ensure that the correct conclusions are addressed in the label," Short said. "That should be resolved pretty soon." Short spoke shortly before the release of an article appearing in the April 20 Journal of the American Medical Association analyzing mortality data associated with the congestive heart failure agent. According to the meta-analysis of three clinical trials involving 862 patients, Natrecor was associated with an 80% increase in the risk of mortality one month after treatment, compared to "traditional" therapy like diuretics and vasodilators. The JAMA meta-analysis was conducted by Jonathan Sackner-Bernstein (North Shore University Hospital) and Keith Aaronson (University of Michigan Medical School), the same authors of an article in the March 21 issue of Circulation suggesting that Natrecor therapy is associated with a higher risk of kidney dysfunction. Short acknowledged that the adverse publicity surrounding Natrecor is having an impact on sales. "There have been some publications and some press reports following those and continue to be," Short said. "There has been some modest impact on the usage at this point." However, she maintained, both the Circulation and JAMA articles do not paint an accurate picture. "What we see is that it's a selective interpretation of existing published data," Short maintained. "There is really nothing that is different than what is in the label." J&J acquired Natrecor as part of the $2.4 bil. Scios acquisition in 2003. - Michael McCaughan |