Treating anaemia in patients with symptomatic heart failure provided a significant improvement in symptoms in a clinical trial, suggesting a potential role for erythropoietin (EPO) drugs in the management of heart failure patients.
The Phase II study of Amgen’s long-acting EPO product Aranesp (darbepoetin alfa), was presented at the American College of Cardiology annual meeting in Atlanta. It found that the product improved patients’ symptoms scores using a questionnaire that measured their ability to carry out tasks such as dressing themselves or climbing stairs, as well as heart failure-related symptoms such as swollen ankles and shortness of breath.
“There is increasing evidence of a link between anaemia and heart failure, and of the potential that treating anaemia in heart failure patients may be beneficial over time," said Dirk van Veldhuisen of University Medical Center in Groningen, Netherlands.
Based on the data, Amgen is now pressing ahead with a Phase III study of Aranesp in heart failure patients with anaemia, called RED-HF.
Anaemia occurs in around 20% to 30% the 23 million patients affected by heart failure worldwide, so approval in this indication could open up big new market for Aranesp, which is currently approved for treating anaemia associated with chronic renal failure and cancer and brought in $3.3 billion in these indications in 2005, a rise of 32% year-on-year.
Amgen is working hard to expand the uses of its Aranesp product to provide some franchise protection as it faces the threat of lower-cost competition to Epogen (epoetin alfa), its short-acting version of the drug, although this is likely to occur first in Europe, where Epogen is not sold, and not in the USA until 2009 or later.
In addition to heart failure, Amgen is developing Aranesp for diabetics with chronic kidney disease and anaemia in the Phase III TREAT study.