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ORTHO’s EPREX IN AZT-RELATED ANEMIA PATIENTS RECOMMENDED FOR APPROVAL BY FDA’s BLOOD PRODUCTS ADVISORY COMMITTEE; RENAL FAILURE DATA NOT CONSIDERED

Executive Summary

Ortho's Eprex (erythropoietin) should be approved for AZT-related anemia in HIV-infected patients, FDA's Blood Products Advisory Committee recommended March 15. The committee voted unanimously, with one abstention, to support FDA's position statement that "Eprex, at a dose of 100 U/kg three times per week, may be effective in decreasing the transfusion requirement and increasing the red blood cell level of anemic, HIV-infected patients treated with AZT, when the endogenous serum erythropoietin level is [less than] 500 mu/mL and when patients are receiving a dose of AZT [less than or equal to] 4,200 mg/week." Ortho received a Treatment IND approval for Eprex in AZT-related anemia patients in June ("The Pink Sheet" July 3, p. 5). "Almost 1,000" patients have been treated under the program, the company says. Fifteen of those individuals were HIV-infected but not receiving AZT. HHS has estimated the potential patient population at 10,000. Although Ortho is also seeking approval of Eprex for use in treating chronic renal failure, the committee's discussion was limited to the AZT-related indication. FDA Division of Blood and Blood Products staffer Joseph Fratantoni reported that the agency has reviewed the data for both indications. Eprex is now being manufactured by Ortho Biologics in England under an agreement with Celltech. Once approved, Ortho plans to supply the U.S. through that plant. Ortho is developing the recombinant erythropoietin product under a licensing agreement with Amgen. However, after a falling out, the two companies are in arbitration. Ortho and Amgen are now awaiting a ruling; arbitration hearings in Chicago were completed in January. Robert Abels, Director of Clinical Research, R. W. Johnson Pharmaceutical Research Institute, presented results from an analysis of combined efficacy data from four double-blind, placebo-controlled studies in anemic HIV-infected patients treated with AZT. The analysis included data from a total of 89 patients treated with Eprex and 88 receiving placebo. Addressing the overall efficacy results from the studies, Abels said Eprex "significantly reduces the number of units of blood per patient per month in comparison with placebo." In addition, Abels noted, erythropoietin can reduce the cumulative units of blood transfused per patient and reduce the number of patients transfused per month. EPO also increases hematocrit levels and improves overall quality of life, "particularly when the hematocrit increases to a low normal range, for instance, approximately 36-40%," Abels said. "The response appears to be maintained with long-term administration." Abels observed that AZT may induce two types of anemic responses in patients. The majority of patients experience low endogenous serum EPO levels (less than 500 mu/mL) with mild transfusion requirements, while a smaller group experiences elevated serum EPO levels and a greater need for transfusions. Abels noted that Eprex does not show a significant therapeutic effect in patients with serum EPO levels over 500 mu/mL. "We believe that our human EPO is safe for the treatment of anemia in HIV infection," Abels told the committee. Discussing the drug's safety profile, Abels said the data show no increase in opportunistic infections or death over placebo; no significant difference in the severity of adverse experiences; and no advancement of the progression of HIV. Unlike patients with chronic renal failure, he noted, the drug is not linked to hypertension or seizures. Moreover, antibodies against Eprex did not develop during therapy, and, over the long run, morbidity and mortality were consistent with the usual course of HIV infection. * In closing remarks, Fratantoni pointed out that the data support an indication only for those HIV-infected anemic patients who are being treated with AZT. FDA will not support an indication for AIDS patients not on AZT with the available data, he emphasized. Furthermore, although Ortho suggested that the initial dose be 100-200 U/kg three times a week, the FDAer recommended limiting the initial dose to 100 U/kg three times weekly because no advantage for a higher dose has been shown. Also, Fratantoni said that the efficacy data do not support use in patients receiving more than 4,200 mg/week of AZT.

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