Sanofi-aventis announced that the National Institute for Health and Clinical Excellence (NICE) in England and Wales, has just published a new appraisal consultation document (ACD) for Multaq (dronedarone) indicating its intention to recommend Multaq use for the management of patients with atrial fibrillation (AF).

The NICE appraisal committee’s preliminary recommendation is to endorse Multaq as a first choice therapeutic option after beta-blockers, which are the initial therapeutic option in the NICE clinical guidelines. Based on this recommendation, Multaq should be prescribed in non-permanent AF patients with at least one of the following cardiovascular risk factors: hypertension requiring drugs of at least two different classes, diabetes mellitus, previous transient ischemic attack, stroke or systemic embolism, left atrial diameter of 50mm of greater, LVEF less than 40% or age 70 years or older and who do not have unstable New York Heart Association (NYHA) class III or IV heart failure.

This patient population corresponds to the patients included in the landmark ATHENA study, the largest study ever performed with an anti-arrhythmic drug in atrial fibrillation and the only study to have ever demonstrated a positive impact on cardiovascular (CV) morbidity and mortality.

In ATHENA, Multaq reduced the risk of cardiovascular hospitalization or death by a significant 24% vs. placebo on top of standard of care including beta-blockers (p<0.001) with no difference in the rate of serious adverse events (19.9% vs 21.1% respectively; p = 0.31).

“Sanofi-aventis is pleased that NICE has acknowledged the benefits of Multaq for non-permanent AF patients who have been awaiting a new therapeutic option that safely treats their symptoms and improves their long-term cardiovascular outcomes,” declared Belen Garijo, senior vice president, Pharmaceutical Operations Europe, sanofi-aventis. “We appreciate the thorough and comprehensive evaluation of the Multaq clinical and economic dossier that NICE has performed and believe that this preliminary recommendation by NICE provides a valuable benchmark to guide sanofi-aventis’ ongoing efforts to have the Multaq value proposition in AF patients recognized within Europe and beyond.”

According to a sanofi-aventis press release, Multaq will be commercially available in the UK from Tuesday, March 30, 2010.

Multaq, discovered and developed by sanofi-aventis, has been studied in a clinical development programme, including seven international, multi-centre, randomized clinical trials involving more than 7000 patients with almost 4000 patients receiving Multaq. The landmark ATHENA trial was the largest antiarrhythmic drug trial conducted in patients with AF/AFL, involving 4,628 patients with a follow-up of 30 months. In this trial, Multaq, on top of standard cardiovascular therapy, significantly reduced cardiovascular hospitalization or death by 24 percent (p<0.001) when compared to placebo, meeting the study’s primary endpoint. This result was entirely attributable to a reduction in cardiovascular hospitalization.

Multaq has a fixed dose regimen of twice daily 400 mg tablets to be taken with morning and evening meals. Treatment with Multaq does not require a loading dose and can be initiated in an outpatient setting. Most common adverse reactions are diarrhoea, nausea, vomiting, abdominal pain, asthenia (weakness) and skin rash.

The European Commission granted marketing authorization for Multaq in November 2009. Multaq is indicated in the EU in adult clinically stable patients with a history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate. The use of Multaq in unstable patients with NYHA class III and IV heart failure is contraindicated. Because of limited experience in stable patients with recent (1 to 3 months) NYHA class III heart failure or with Left Ventricular Ejection Fraction (LVEF) <35%, the use of Multaq is not recommended in these patients

Multaq is currently available in the US, Canada, Switzerland, Germany, Denmark, Ireland, Norway and Finland and is being launched in most European countries in 2010.