The European Medical Association is to re-assess the risks attributed to Sanofi’s drug Multaq, reports inpharm.com.
Following reports of serious liver failure in patients taking Multaq, and the halting of the drug’s phase III trial, the EMA is looking into the drug’s risk-benefit profile. The phase III trial found that major cardiovascular events were higher amongst patients taking Multaq, rather than those using the placebo.
Multaq is expected to reach US sales of $521 million by 2016 following its approval in 2009 throughout Europe and the US for use in atrial fibrillation patients.
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