Switzerland's Vifor Pharma is celebrating after getting the thumbs-up from US regulators for Injectafer for the treatment of iron deficiency anaemia.

The US Food and Drug Administration has approved the treatment, sold in Europe as Ferinject (ferric carboxymaltose) since getting the green light in 2007. Specifically, Injectafer will be available for the treatment of IDA in adults who have had an unsatisfactory response or are intolerant to oral iron.

The approval is based on two large trials conducted by Vifor's US partner Luitpold Pharmaceuticals which studied more than 3,500 patients, of which 1,800 were treated with Injectafer.

Vifor noted that Injectafer is the first non-dextran intravenous iron therapy to gain FDA approval for the treatment of IDA "in a diverse group of patients with this debilitating condition, irrespective of the underlying origin". It is also indicated for IDA in adults with non-dialysis dependent chronic kidney disease.

Luitpold will immediately launch the product which will be made at its manufacturing facility in Columbus, Ohio. In the USA there are an estimated 7.5 million people with IDA, a condition that occurs when body iron stores are inadequate for normal red blood cell production.