FDA backs REMS plan for Amgen and J&J's anaemia drugs

Johnson & Johnson and Amgen have been boosted by approval from regulators in the USA for the companies' risk management strategy for patients with chemotherapy-induced anaemia who take the firm’s erythropoiesis-stimulating agents.

Sales of the ESAs, ie Amgen's Aranesp (darbepoetin alfa) and Epogen (epoetin alfa), and J&J's Procrit (also epoetin alfa) have suffered ever since 2006 when a study linked the drugs to a greater risk of heart attacks, stroke and death at high doses. Then, in 2008, the US Food and Drug Administration told Amgen and J&J that a risk evaluation and mitigation strategy was necessary to ensure the benefits of the ESAs outweigh the risks of “shortened overall survival and/or increased tumour progression or recurrence as identified in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancers”.

So, as of March 24 and as part of the REMS programme which has been given the go-ahead, doctors will be required to undergo “specific training and certification” on the risks and benefits of the drugs in order to continue prescribing the ESAs to cancer patients. Medics must also discuss the risks, benefits, and FDA-approved uses of ESAs with patients who have cancer before beginning a course of treatment “and document this discussion with a written acknowledgement from the patient”.

An FDA review is also underway regarding the use of ESAs in patients with chronic kidney disease. The companies will be hoping that the plan may mark a change in fortunes for the drugs, as Aranesp sales fell 15% to $2.65 billion in 2009, while Procrit slipped some 9% to $2.25 billion.