Multaq raises risk of death in permanent AF patients
pharmafile | November 16, 2011 | News story | Sales and Marketing | AF, Multaq, Sanofi
More bad news for Sanofi’s Multaq as new data shows the drug doubles the risk of death in people with permanent abnormal heart rhythm.
Final results from the PALLAS study showed that risk of stroke, heart attack or death from cardiovascular causes was 2.2 times greater for patients taking Multaq (dronedarone) than for those on placebo.
Multaq is licensed to treat adults who have had atrial fibrillation (AF) in the past, or who currently have intermittent AF, but PALLAS was evaluating it in patients who were 65 years old or more with permanent AF and other risk factors for vascular events.
The trial was halted in July after researchers found evidence of serious vascular events and deaths – less than a third of the planned 10,800 patients eventually took part.
Delegates at the American Heart Association’s Scientific Sessions 2011 were told that 43 people taking Multaq, and 19 in the placebo arm, suffered a stroke, heart attack, systemic blood clot or cardiovascular death.
“The message is that the drug dronedarone should not be used for permanent AF,” said Stuart J. Connolly, lead author of the study.
PALLAS is the latest on a list of setbacks for Multaq. In September, the European Medicines Agency recommended its use should be restricted due to ongoing concerns about safety.
This followed a review by the CHMP in which increased risks of liver and lung adverse events were seen.
Such worries have effectively finished off the drug’s commercial profile, having once been tipped as a multi-billion dollar blockbuster. The drug gained approval in Europe and the US in 2009, but earned just €131 million in the first half of 2011.
Adam Hill
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