Amgen Inc., of Thousand Oaks, Calif., has received an approvable letter from the FDA for Aranesp (darbepoetin alfa) for de novo once-every-two-week dosing and for once-monthly maintenance dosing for non-dialysis CKD patients with anemia. The FDA has requested more clinical data for the once-monthly regimen, including an additional clinical study.
The letter also asks for additional label language and clarification of data that was submitted for the de novo once-every-two-weeks regimen. Amgen is committed to working closely with the FDA to resolve these questions rapidly and efficiently.
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