The regulatory body also requested additional label language and clarification of already submitted data. Amgen submitted a biologics license supplement to the FDA for Aranesp in December 2005.
Amgen said that it is committed to working closely with the FDA to resolve these questions in a timely and efficient manner.
Aranesp is a version of Amgen’s anemia drug Epogen. Aranesp was approved by the FDA in 2001 for the treatment of anemia in patients with kidney failure and was also approved for cancer patients.
According to the National Kidney Foundation, CKD affects 20 million Americans and more than 20 million others are at increased risk for developing kidney disease.