J&J Ends Plan To Seek Wider Procrit Use

Johnson & Johnson called off plans to seek a broader list of approved uses for its drug Procrit, after the drug failed to show a reduction in the need for red-blood-cell transfusions among critically ill patients.

The finding, published today in the New England Journal of Medicine, is the latest blow to Procrit and other forms of erythropoietin, or EPO, a hormone that stimulates red-blood-cell production and is used widely in cancer, kidney and HIV patients.

In March, J&J added a prominent notice to Procrit's label, warning of an increased risk of death, heart attacks, and tumor growth in some situations, after studies indicated such risks. Next week, a Food and Drug Administration panel will hold a hearing on risks to kidney patients. Procrit sales have fallen 21% from two years ago.

The FDA has approved Procrit to treat anemic patients going into surgery or chemotherapy, and those who have kidney failure or HIV. J&J wanted to broaden that list to include anemic patients in an intensive-care unit, irrespective of a particular disease.

In the study, which J&J funded, doctors enrolled 1,460 ICU patients. Half received three injections of Procrit over a 15-day period, and the other half received a placebo.

A previous J&J study, published in 2002, suggested Procrit would reduce the need for red-blood-cell transfusions, but the latest study didn't show a reduction. As a result, J&J is calling off its attempt to broaden the drug's approved uses, a spokeswoman said.

Doctors are allowed to prescribe Procrit in the intensive-care unit anyway, but few do, said Aryeh Shander, the chief of the department of anesthesiology and critical-care medicine at the Englewood Hospital in Englewood, N.J. Today's study is likely to decrease such "off-label" use, said Dr. Shander, who has received grants and consulting fees from J&J.

In today's study, Procrit patients showed a drop in deaths, but the result wasn't statistically significant. Procrit did increase the risk of blood clots and other "thrombotic vascular" events, by roughly 40%, confirming the FDA's warnings and previous studies.

Procrit is made by Amgen Inc., which gets a 10% royalty from J&J. It sells the same drug to kidney patients undergoing dialysis as Epogen. J&J also sells a different synthetic erythropoietin, Eprex, internationally. J&J sold $758 million of Procrit and Eprex in the quarter ended in June.