Researchers at the University of California at San Francisco (UCSF)reported that clinical trials of recombinant erythropoietin (EPO),which boosts red blood cell production, showed the drug wassuccessful in reducing the need for transfusions to treat anemia inprematurely born babies.
Kevin Shannon, assistant professor of pediatrics at UCSF, saidresults showed the drug, which was developed by Amgen Inc. andlicensed to Johnson & Johnson, achieved statistical significance as aneffective treatment for anemia.
The 18-month trials involved 157 babies at 11 U.S. medical centers.Forty-three percent of the patients receiving EPO did not require ablood transfusion compared with 31 percent in the placebo group.
Shannon was co-author of an article detailing the trials' findings inthe January issue of Pediatrics. The researchers said the drug couldhelp 40,000 premature babies a year in the U.S. who typicallyundergo four to 10 blood transfusions during the first few weeks oflife. EPO is safer than transfusions, the authors pointed out, becausethere is no risk it will be incompatible with the babies' blood and norisk of contamination.
Although the drug already is marketed in the U.S. and around theworld for other uses, it has not been approved by the FDA foranemia in premature babies.
Thousand Oaks, Calif.-based Amgen sells it as Epogen for anemia inkidney disease patients on dialysis. Johnson & Johnson's subsidiary,Ortho Biotech, of Raritan, N.J., sells it in the U.S. as Procrit foranemia associated with AIDS patients taking AZT and with patientson chemotherapy.
Johnson & Johnson also has rights to sell the drug for all indicationsoutside the U.S. and markets it under the name Eprex.
Ortho Biotech has not decided whether it will conduct additionaltrials if required by the FDA to get labeling for premature babies,who would constitute a relatively small market population for thedrug.
Bruce Williams, Ortho Biotech's executive director of marketing,said the studies in premature babies are among numerous pilot trialsbeing conducted to define broader uses for EPO. He said thecompany is evaluating those studies to determine how it will proceedin seeking FDA clearance for additional indications. n
-- Charles Craig
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