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Multaq given restricted NICE approval

After rejecting the drug earlier this year, the UK's NICE has given sanofi-aventis's Multaq limited approval as a second-line treatment for atrial fibrillation

The UK National Institute for Health and Clinical Excellence (NICE) has published final guidance on the use of Multaq (dronedarone, sanofi-aventis). The drug is now recommended as a second-line option for the treatment of non-permanent atrial fibrillation under certain conditions.

Conditions for the use of Multaq are that it be administered only in people whose atrial fibrillation is not controlled by first-line therapy (usually beta blockers), who do not have unstable New York Heart Association (NYHA) class III or IV heart failure and who have at least one of the following cardiovascular risk factors:

•  hypertension requiring drugs of at least two different classes
•  diabetes mellitus
•  previous transient ischaemic attack, stroke or systemic embolism
•  left atrial diameter of 50mm or greater
•  left ventricular ejection fraction less than 40 per cent
•  aged 70 years or older.

Multaq was approved in the US in July 2009 and in Europe in November 2009. The UK approval is in line with NICE's Final Appraisal Determination, which was published on July 15. However, in January Multaq had been rejected by NICE, which felt that its cost of £2.25 per day (compared to £0.05 per day for generic amiodarone) made it a cost-ineffective treatment option. Additionally, US research published in the Journal of the American College of Cardiology in April 2010 indicated that dronedarone is only half as effective as amiodarone and does not have fewer side effects.

"The overall assessment is that dronedarone has only modest efficacy and no clear-cut safety advantage," Dr Sanjay Kaul, the lead study author, said in an interview.

Despite this, NICE reversed its original assessment after deciding that Multaq offered an advantage over other currently available clinical treatments in that it does not raise the risk of mortality in treated patients.

There have been no new therapeutic options for atrial fibrillation for 20 years and Multaq has been in development for 15 years. Multaq is indicated in adult clinically stable patients with a history of, or current, non-permanent atrial fibrillation to prevent recurrence or lower ventricular rate.

Further information about Multaq can be found from the Multaq website.

25th August 2010

From: Healthcare

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