Preliminary Data from Experimental Study Demonstrate Increased Mortality in Stroke Patients Treated With Epoetin Alfa
Bridgewater, NJ (September 17, 2008) - Ortho Biotech has become aware of preliminary data from an investigator-initiated experimental study of the effects of Epoetin alfa in patients with acute ischemic stroke. In this study, patients suffering acute ischemic stroke who were treated with Epoetin alfa within six hours of the onset of stroke symptoms died more frequently than patients receiving placebo. Ortho Biotech has reported this information to the U.S. Food and Drug Administration and to European regulatory authorities. Additional analyses are underway to better understand these preliminary results.
Epoetin alfa is marketed as EPREX® / ERYPO® outside the U.S. by Janssen-Cilag, as PROCRIT® in the U.S. by Ortho Biotech and as EPOGEN® in the U.S. by Amgen. None of these products are approved in any country for use in patients with acute ischemic stroke. Epoetin alfa is a member of the class of erythropoiesis stimulating agents (ESAs). ESAs should be used strictly in accordance with their approved indications and dosing recommendations.
This investigator-initiated experimental study was designed and conducted by an investigator in Europe. Ortho Biotech provided study drug and funding, but the company had no role in designing or conducting the study. The investigator has informed the company that the results of this study will be submitted for publication promptly.