Amgen’s anaemia treatment Aranesp could be another treatment option for patients with heart failure, according to the results of two Phase II clinical trials.
Although the results of the programme did not reach statistical significance, commentators said that Aranesp (darbepoetin alfa) reduced the risk of hospitalisations and death in heart failure cases, suggesting that larger trials of the treatment are warranted. Amgen has already started a 3,400-patient Phase III trial – called RED-HF – to test the hypothesis.
Results from a first Phase II study were reported at the American College of Cardiology meeting in March. The latest analysis, presented at the European Society of Cardiology-Heart Failure meeting, add to and reinforce the earlier findings, said Amgen.
The latest, one-year study of Aranesp enrolled 319 patients with symptomatic heart failure who received either placebo or Aranesp. Results showed trends suggestive of a benefit in exercise duration and clinical outcomes, including first heart failure hospitalization and mortality.
The pooled analysis of both studies also suggested that Aranesp could improve all-cause mortality and/or first heart failure-related hospitalisation, and heart, but once again the trend did not reach statistical significance.
Amgen spokesman Scott Wasserman said in a conference call that the ‘arrows were pointing the right direction’ for Aranesp, emphasising that the studies were designed to prove safety, not efficacy, of the drug in this setting.
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.