Sanofi-aventis has announced today 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(R) (dronedarone) indicating its intention to recommend Multaq(R) use for the management of patients with atrial fibrillation (AF).
The NICE appraisal committee's preliminary recommendation is to endorse Multaq(R) 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(R) 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(R) 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(R) 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(R) 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(R) value proposition in AF patients recognized within Europe and beyond."