Sanofi’s Multaq in the dock
pharmafile | September 7, 2011 | News story | Sales and Marketing | Multaq, Sanofi
The EMA will later this month decide whether Sanofi’s Multaq can remain on the market after reports emerged of serious adverse events.
The Agency approved the drug in Europe in late 2009 in adults who have had atrial fibrillation (AF) in the past or who currently have non-permanent atrial fibrillation.
But since 2009 a series of adverse events – including cardiovascular problems, liver and lung injuries – have consistently been reported with the use of Multaq.
This had prompted a review of the drug by the Agency’s safety and efficacy arm the CHMP, which will discuss all of the new safety data at its next meeting on the 19-22 September.
The CHMP’s findings will then be sent to the EMA which will decide what action to take. Depending on the outcome, Multaq (dronedarone) could be withdrawn from the European market if it is deemed to be a greater risk than a benefit to AF patients.
Alternatively, if the Agency believes that it can still show some benefit despite the safety problems, its use may be restricted to a smaller set of patients or be subject to a series of safety warnings.
Multaq faces scrutiny in the US
The drug’s approval in the US also came in 2009, when the FDA licensed it to reduce the risk of cardiovascular hospitalisation in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm (normal heart beat) or who will be cardioverted (have an abnormally fast heart rate converted to a normal rhythm).
But the US regulator has also been concerned over Multaq’s safety, and in July of this year published the PALLAS study, sponsored by Sanofi, evaluating the effects of the drug in patients with permanent atrial fibrillation.Such was the concern over its safety that the study was stopped early after twice as many permanent AF patients died taking Multaq, compared to those that did not.
The FDA is still assessing the PALLAS data and said it would review the final results when they become available.The regulator added that it has not yet concluded whether the results of the study are applicable to patients taking Multaq for paroxysmal or persistent atrial fibrillation or atrial flutter.
Multaq failed to take off as analysts predicted, and brought in just 131 million euro in the first half of this year, despite being on the market since 2009.
Persistent safety concerns have hampered the sales trajectory, and the upcoming decisions from the regulators has brought the drug to a tipping point.
Ben Adams
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