Amgen’s hopes of developing its red blood cell stimulator Aranesp as a heart failure treatment were dashed after it reported negative results in a phase III trial.
Data from the RED-HF study showed there was no difference between Aranesp (darbepoetin alfa) and placebo in preventing a composite measure of time to death from any cause or first hospital admission for worsening heart failure.
RED-HF was started in 2006 after several epidemiological studies suggested there was an association between heart failure and anaemia, including a correlation with increased mortality risk and hospitalisation rates in patients with low haemoglobin counts.
Amgen set a target of raising haemoglobin levels to at least 13g/dL in the study, which involved almost 2,300 patients with symptomatic left ventricular systolic dysfunction.
The failure of RED-HF to show any benefit in heart failure patients is reminiscent of the results of an earlier study called TREAT, which also showed no benefit Aranesp on death and cardiovascular endpoints in diabetic patients with chronic kidney disease and anaemia.
Aranesp is already approved to treat anaemia associated with chronic kidney disease and cancer chemotherapy, bringing in $1.55bn in the first nine months of 2012, but has been in steady decline owing to changes to its labelling to reflect an increased risk of blood clots.
Meanwhile, in June 2011 the US FDA issued guidance suggesting that Aranesp and other red blood cell stimulators such as Amgen’s older drug Epogen (epoetin alfa) should be used with care in chronic kidney disease patients because of an increased risk of cardiovascular events.
The company said there were no new safety findings identified in the RED-HF study. It will now carry out safety and efficacy analyses on the results and submit the data for presentation at a medical meeting.
In December, Amgen admitted that it used illegal marketing practices to promote Aranesp in the US and agreed to pay more than $760m in fines and settlements to resolve a number of whistleblower lawsuits.