The US Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee has voted 10 to three in favour of approving sanofi-aventis’ Multaq for the treatment of patients with non-permanent atrial fibrillation (AF), as expected.

The news will obviously be welcomed by the company’s shareholders, although the group’s stock had already been given a boost yesterday after documents posted on the FDA’s website ahead of the Committee’s meeting were in favour of giving the product the green light.

Approval of Multaq (dronedarone) was recommended on the back of a strong clinical trials programme, which not only demonstrated the drug’s efficacy on rhythm and rate in AF and atrial flutter (AFL), but also its clinical benefit on cardiovascular hospitalisations or death in patients with recent history of or current AF/AFL.

“Since none of the existing anti-arrhythmic drugs have ever demonstrated efficacy on morbidity/mortality outcomes, dronedarone represents a new advance in the management of patients with AF and AFL, addressing an important unmet clinical need for patients and physicians,” the Committee concluded.

Encouraging data
The Paris-headquartered company has recently unveiled a catalogue of promising data on the drug, including an analysis of a previously reported data which showed that Multaq cut the total number of hospital days in patients with AF by 28% compared to placebo and slashed the total length of time spent in the hospital for heart-related reasons by 35%.

Analysts are expecting the product to rake in sales of around $2 billion a year if it makes it to market, but its path so far has been far from smooth; in 2006, the FDA issued a ‘not-approvable’ letter for the drug, seeking more clinical evidence of its efficacy and safety. However, following the Committee’s support it looks as though these issues have now been addressed.

The FDA, which does not have to follow the recommendations of its advisory committees, is expected to make its final decision on whether to approve Multaq by April 30. If a green light is issued, the drug will represent the first new AF therapy to be launched for more than two decades, according to media reports.