Multaq given limited approval from NICE

Multaq is recommended as a second line therapy

NICE has given a restricted approval to Sanofi-Aventis’s Multaq as a second line treatment for atrial fibrillation patients.

The guidance recommends using Multaq (dronedarone) only as a second line treatment in patients with additional cardiovascular factors whose non-permanent atrial fibrillation (AF) has not been controlled by first line therapy, usually involving beta blockers.

NICE states that Multaq should only be used in patients:

• Who have hypertension that requires drugs of at least two different classes
• Have diabetes mellitus
• Have had a stroke or systemic embolism
• Have a left atrial diameter of 50mm or greater
• Aged 70 years or older
• Who do not have unstable New York Association class III or IV heart failure
• And patients who have left ventricular ejection fraction less than 40% 

The cost-effectiveness body was originally minded not to recommend the treatment, saying in January that it was too costly when compared to the generic alternative amiodarone.

It changed its mind in the latest series of draft guidance after being persuaded that Multaq was an advance over currently available treatments.

In particular, NICE said amiodarone and other anti-arrhythmia drugs carried with them the risk of raised mortality in patients, something not seen in Multaq’s data.

Multaq is used on patients who have experienced an irregular heartbeat, atrial fibrillation or atrial flutter within the past six months, but who may currently have a regular heart rhythm or will have medical treatment to return to a regular rhythm.

Multaq gained US approval in July 2009 and European approval in November, and is one of Sanofi’s most important new products.

This will come as a boost to the French company as it is depending on new drugs such as Multaq to sustain sales and offset generic competition.

Ben Adams