Sanofi-aventis’ Multaq given preliminary NICE recommendation

Sanofi-aventis’ atrial fibrillation drug Multaq has been granted a preliminary recommendation by the UK’s National Institute for Health and Clinical Excellence (NICE).

In its final draft guidance for the new treatment, the regulatory body has confirmed its earlier decision to endorse the drug as a second-line treatment among patients with additional cardiovascular risk factors that have proven unresponsive to other therapies.

The draft has now been referred to consultees for further discussion, with final guidance set to be issued to the NHS in August 2010.

Explaining the decision, NICE chief executive Sir Andrew Dillon said that although Multaq is not as effective in preventing atrial fibrillation recurrence as other treatments, it is also associated with fewer side effects.

He stated that this attribute may mean that patients will prefer to use Multaq, as the side effects associated with current antiarrhythmic drugs can have a “significant impact on quality of life with long-term use”.

In May 2010, Sanofi-aventis initiated a large-scale international phase IIIb trial of Multaq, which is set to involve more than 10,000 patients.