THOUSAND OAKS, Calif., Oct. 18 /PRNewswire-FirstCall/ — Amgen
(Nasdaq:
AMGN) will review the results from TREAT (the Trial to Reduce
Cardiovascular Events with Aranesp® Therapy) and will discuss
how these results inform the appropriate use of
erythropoiesis-stimulating agents (ESAs) for chronic renal failure
(CRF) patients at today’s meeting of the Food and Drug
Administration’s (FDA) Cardiovascular and Renal Drugs Advisory
Committee (CRDAC).
“This advisory committee meeting is a valuable forum for the
FDA, Amgen and the nephrology community to review the results from
TREAT, which further inform use of ESAs in patients with chronic
renal failure who are not on dialysis,” said Reshma Kewalramani,
M.D., FASN, executive director, Global Development at Amgen. “We
look forward to sharing our analyses of TREAT and describing
proposed label changes that will help guide nephrologists in
focusing their use of ESA therapy on patients most likely to
benefit.”
TREAT, the largest study of ESA use in CRF patients to date, is
a randomized, double-blind, placebo-controlled, Phase 3 study of
patients with moderate kidney dysfunction who were not on dialysis,
had moderate anemia and type-2 diabetes and were treated to a
hemoglobin target of 13 g/dL, a higher level than recommended in
the current approved ESA label. The study did not meet its
endpoints of demonstrating a reduction in all-cause mortality,
cardiovascular morbidity or end-stage renal disease and showed an
increased risk of stroke in the Aranesp (darbepoetin alfa) arm,
among other key findings.
The results from TREAT provide important information about the
cardiovascular risks of treating CRF patients with ESAs to a
hemoglobin target of 13 g/dL or greater. Cardiovascular risks have
been reflected in the boxed warning of the FDA-approved ESA labels
since 2007 and, in December 2009, Amgen further strengthened
the
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