Merck said that it is taking these steps based on the current understanding of the preliminary data from the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study and in consultation with regulatory authorities.
Reportedly, the HPS2-THRIVE study did not achieve its primary endpoint of reduction of major vascular events and there was a statistically significant increase in the incidence of some types of non-fatal serious adverse events in the group that received TREDAPTIVE compared to statin therapy.
This decision to suspend availability of the medicine is aligned with the recommendation of the European Medicine Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) based on the trial’s results.
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