FDA Expands Indication of CKD Drug

The US Food and Drug Administration (FDA) has approved the expansion of the existing label for Feraheme (ferumoxytol injection) beyond its current indication for patients with chronic kidney disease (CKD) to include certain patients without CKD.

The new label will now include all eligible adults with iron deficiency anemia (IDA) who have intolerance or unsatisfactory response to oral iron.

The approval was granted following the success of 2 phase 3 trials that had assessed Feraheme vs iron sucralose or placebo in a large cohort of patients with IDA, as well as a third successful phase 3 trial that compared Feraheme with Injectafer (ferric carboxymaltose injection).

—Christina Vogt

Reference:

AMAG Pharmaceuticals announces FDA approval of supplemental new drug application (sNDA) for Feraheme (ferumoxytol injection) [press release]. Waltham, MA. AMAG Pharmaceuticals. February 5, 2018. https://globenewswire.com/news-release/2018/02/05/1332857/0/en/AMAG-Pharmaceuticals-Announces-FDA-Approval-of-Supplemental-New-Drug-Application-sNDA-for-Feraheme-ferumoxytol-injection.html. Accessed on February 6, 2018.