Sanofi-Aventis’ dronedarone looks likely to help fill the unmet need for a drug treatment that can control atrial fibrillation effectively without risking serious side effects, cardiology experts commented this week. Professor Bramah Singh of the UCLA School of Medicine, Los Angeles, said at the American Heart Association meeting this week that pivotal trials of more than 1,200 patients show dronedarone is as effective as the gold standard amiodarone but without the organ toxicity problems associated with the latter’s long-term use. New data presented by Prof Singh show dronedarone works well across different patient subgroups.
Dronedarone is a class III multi-channel blocking anti-arrhythmic drug currently in Phase III development for the prevention of atrial fibrillation and atrial flutter. The drug was filed with the FDA and EMEA in June this year.
New data from the Phase III EURIDIS trial presented at AHA by Professor Stefan Hohnlose from Goethe University, Frankfurt, showed dronedarone significantly reduced all-cause hospitalisations or deaths by 27% compared to placebo in patients with paroxysmal and persistent AF. And data from an additional Phase III study, ERATO, also presented at AHA, showed dronedarone is able to control heart rate in patients inadequately controlled by concomitant standard therapies as well as improve exercise.
Several companies are chasing the growing AF market with numerous drugs in the pipeline, but dronedarone is seen as one of the strongest contenders to fill the unmet need for a good drug-based maintenance therapy.
Professor Peter Kowey of Jefferson Medical College, Philadelphia, said an effective, safe treatment is desperately needed. “AF is an epidemic sweeping through the population of ageing baby-boomers in developed countries. It increases the risk of stroke five-fold and is a major cause of rising healthcare costs.” AF affects 2.5 million people in the US alone and is estimated to account for between 15 and 20 per cent of all strokes. Prevalence is expected to reach 5.6 million in the US by 2050. In the UK, AF affects 5% of the over 65 population and 10% of over 75s.
“Dronedarone is so important we expect the FDA to hold an advisory committee in spring 2006 prior to its decision on licensing approval,” he commented.
Source: Olwen Glynn Owen at the AHA in Dallas, USA.