Amgen updates ESA prescribing information

Amgen has updated the US prescribing information for its erythropoiesis-stimulating agents (ESAs) Aranesp (darbepoetin alfa) and Epogen / Procrit (Epoetin alfa).

The decision to modify the products’ package inserts follows discussions with both the US Food and Drug Administration (FDA) and Johnson & Johnson Pharmaceutical Research & Development (J&JPRD).

Changes to the labelling include alterations to the boxed warnings, additional entries in the Indications and Usage section, an addition of an oncology study in the Warnings section as well as a clarification of the haemoglobin range for chronic renal failure patients in the Dosage and Administration section.

The company also announced that it has developed six additional studies to add to its current pharmacovigilance programme which addresses questions about ESA safety.

“Amgen has been working closely with the FDA and J&JPRD to ensure that the information contained in the approved labelling for ESAs accurately reflects the current state of knowledge of these important products,” said Roger M Perlmutter, executive vice-president of Research and Development at Amgen.

He added that the company had also worked with the bodies to develop a “comprehensive and feasible clinical study program to complement our existing pharmacovigilance program”.

Also this week, Amgen and Wyeth Pharmaceuticals reported new data showing that half of patients with active early rheumatoid arthritis achieved clinical remission after one year when treated with Enbrel (etanercept) plus Methotrexate.