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NICE positive on anti-arrhythmic drug

NICE have issued a preliminary recommendation for sanofi-aventis' Multaq, an anti-arrhythmic drug addressing unmet need in atrial fibrillation

The National Institute for Health and Clinical Excellence (NICE) has issued a new positive preliminary recommendation for Multaq (dronedarone) for the treatment of non-permanent atrial fibrillation (AF), the most common form of abnormal heart rhythm.

Sanofi-aventis (S-A), who developed the drug, described it as "one of the major therapeutic innovations in the field of AF in approximately 20 years" with its use in the treatment of AF in people with a cardiovascular risk factor whose condition is not controlled by standard rate controlling therapies such as beta blockers.

Multaq is the only anti-arrhythmic drug (AAD) to have shown a significant reduction in morbidity and mortality versus placebo on top of standard therapy in adult patients who have non-permanent AF.  It has also been shown to cause fewer side effects than other medicines, with the most frequent adverse reactions observed being diarrhoea, nausea, vomiting, fatigue and asthenia.

In the ATHENA study – the largest AAD trial ever conducted in AF with 4,628 patients enrolled in 551 sites across 37 countries – Multaq, on top of standard therapy and anticoagulants, was shown to reduce the risk of cardiovascular hospitalisation or death from any cause in patients with non-permanent AF by 24 per cent and reduce the risk of cardiovascular hospitalisation by 26 per cent, when compared to placebo.

The drug was also shown to reduce the risk of time to first AF recurrence by 22 per cent versus placebo, when used on top of beta-blockers. 

Multaq is licensed for use in adult patients who have non-permanent (paroxysmal or persistent) AF. Marketing authorisation for the drug was granted by the European Commission in late 2009 and the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the European Commission in September 2009. 

According to Dr Derick Todd, consultant electrophysiologist at the Liverpool Heart and Chest Hospital: "The treatment of AF is about making patients feel better and protecting them from the negative health outcomes associated with AF. I am excited by the launch of dronedarone, which is a valuable additional choice for the treatment of AF. For the first time I will feel that a drug I use to treat AF will also reduce the morbidity associated with AF, such as hospitalisation, stroke and cardiovascular mortality."

The economic burden of AF is currently considerable, with the Office of Health Economics estimating the total direct cost to the NHS in the UK amounting to £429m in 2008. Current treatment for AF involves a choice between effective control of AF and protecting patients from serious toxiticities. 

The stakeholder consultation period for NICE's ACD closes on April 22 and S-A has said it will continue to work closely with the body in the final stages of the single technology process. Final guidance is expected later in the year.

30th March 2010


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