EMA widens safety review of Sanofi’s Multaq
pharmafile | July 12, 2011 | News story | Sales and Marketing | Multaq, Sanofi
European regulators are to extend their assessment of the risks associated with Sanofi’s atrial fibrillation (AF) medicine Multaq to take in reported cardiovascular issues.
The European Medicines Agency has been looking at the brand’s risk-benefit profile since January, following reports of severe liver injury.
But earlier this month, Sanofi halted the key PALLAS study after severe cardiovascular events in some patients taking Multaq (dronedarone).
The EMA’s Committee for Medicinal Products for Human Use will now broaden its review to take in information from PALLAS, deciding on further action to take at a meeting next week.
In the phase IIIb trial, Multaq – one of the French manufacturer’s most important new products – was being investigated in more than 3,000 patients over 65 years of age with permanent AF.
This is a different patient population from that for which Multaq has been approved in the EU since November 2009 – those who currently have, or have had, non-permanent AF.
PALLAS was looking at major cardiovascular events (such as stroke or myocardial infarction) or hospitalisations due to them, or death – and found a higher rate with Multaq compared with placebo.
Stuart Connolly, PALLAS’s co- principal investigator, said he was “very disappointed to discover that the hypothesis that dronedarone would improve major outcomes for this high risk patient population has been refuted”.
The cessation of the study, and the subsequent widening of the CHMP probe, is another blow for Sanofi which had hoped Multaq would reach blockbuster status.
It is used to treat patients who have had an abnormal heart rhythm during the past six months, and analysts suggested sales in the US – where it was given the green light in July 2009 – will hit $521 million in 2016.
The US indication is for reducing the risk of cardiovascular hospitalisation in patients with paroxysmal or persistent AF or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors.
UK cost effectiveness body NICE has already given Multaq restricted approval as a second line treatment for patients with additional cardiovascular factors whose non-permanent AF has not been controlled by first line therapy, usually involving beta blockers.
And the European Society of Cardiology guidelines on treating AF have also recommended Multaq.
“Patient safety is of highest priority for Sanofi,” said Jean-Pierre Lehner, Sanofi’s chief medical officer, when PALLAS was halted.
“We remain committed to Multaq as an essential treatment option for non-permanent AF patients,” he added.
Adam Hill
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