FDA Advisors Go Easy on Aranesp (darbepoetin alfa) 1

The FDA Cardiovascular and Renal Advisory Committee went easy today on Aranesp (darbepoetin alfa), the embattled erythropoeisis-stimulating agent (ESA).  After considering the implications of the Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT), the committee recommended that no additional restrictions or label changes be made for the drug. However, the vote hardly represents a ringing endorsement of the drug by the committee. Instead, most members felt that the current label already reflects the findings from TREAT and sufficiently restricts the drug’s use. (Following the publication of TREAT a year ago the drug’s label was changed to reflect More…