Roche sees Mircera receive FDA approval

Roche has announced that the US Food and Drug Administration (FDA) has approved Mircera for the treatment of anaemia associated with chronic renal failure (CRF) in adult patients both on and off dialysis treatment.

The FDA’s decision follows on from Mircera’s approval by the European Agency for the Evaluation of Medicinal Products which means that it is already available in a number of European countries.

However, patients in the US will still have to wait on an ongoing patent case that will determine when the drug becomes available.

Following FDA approval, Mircera is now the only erythropoiesis-stimulating agent to provide correction of anaemia with once-every-two-week dosing and which is also able to maintain stable haemoglobin levels with once-monthly or once-every-two-week dosing in CRF patients.

George B Abercrombie, president and chief executive officer of Hoffmann-La Roche, expressed his delight at the decision.

He added: “In Europe, thousands of patients with CRF and their physicians are receiving effective, predictable and convenient anaemia treatment with Mircera, and we are hopeful that patients and healthcare providers in the US will be able to have access to Mircera as soon as possible.”

Last month, Roche announced that the European commission had approved its new smaller child-sized Tamiflu (oseltamivir) capsules of 30mg and 45mg doses.