Vifor gains US FDA approval for Injectafer

Switzerland-based Vifor Pharma, part of the Galenica group (SIX: GALN), has received approval from the US Food and Drug Administration for Injectafer (the US brand name of Ferinject [ferric carboxymaltose]) for the treatment of iron deficiency anemia (IDA).

Luitpold Pharmaceuticals, a subsidiary of Japanese drug major Daiichi Sankyo (TKO: 4568), the US partner of Vifor Pharma, will launch the product and produce Injectafer at the Luitpold manufacturing facility in Ohio.

Injectafer is approved for IDA in adult patients who have had an unsatisfactory response or intolerance to oral iron, and is the first non-dextran intravenous iron therapy to gain US FDA approval for this indication. It is also indicated for IDA in adult patients with non-dialysis dependent Chronic Kidney Disease (ND-CKD).