Three months after Sanofi discontinued a Phase IIIb trial in patients who were treated with its Multaq heart med due to a significant increase in cardiovascular events, the European Medicines Agency has finished a promised review and decided to restrict use of the controversial drug. The move adds pressure on the FDA, which is conducting its own review, to take similar steps.
"Due to an increased risk of liver, lung and cardiovascular adverse events, Multaq should only be prescribed after alternative treatment options have been considered," the EMA says in its statement, adding, however, that "for some patients with non-permanent atrial fibrillation, Multaq remains a useful treatment option."
The med was two years ago to lower the risk of cardiovascular hospitalization in patients with persistent atrial fibrillation or atrial flutter who have had a recent episode and associated cardiovascular risk factors. But the study that was halted, which was called PALLAS, had been looking at people who suffer from permanent atrial fibrillation (see here). As a result, this raised serious questions about the extent to which the drug can hurt the intended population.
This is only the latest setback for Sanofi and its Multaq heart med, which is supposed to bolster flagging fortunes. Earlier this year, French regulators reevaluated the effectiveness of the drug after two patients developed severe liver damage and decided Multaq is “insufficient,” which means French authorities could withdraw reimbursement (read this).
heart attack pic thx to bart on flickr