BioCentury
ARTICLE | Clinical News

Tredaptive regulatory update

January 28, 2013 8:00 AM UTC

EMA's CHMP confirmed a recommendation from the agency's Pharmacovigilance Risk Assessment Committee to suspend marketing authorization of Tredaptive in the EU. EMA began a review of the drug in December after data from the investigator-led Phase III HPS2-THRIVE trial showed that the cardiovascular drug plus statin therapy failed to reduce the incidence of cardiovascular events and also increased the incidence of non-fatal serious adverse events. The agency said doctors should no longer prescribe the drug and should review treatment plans for patients receiving the drug. Earlier this month, Merck said it would suspend worldwide availability of the drug based on the HPS2-THRIVE data (see BioCentury, Dec. 24, 2012 & Jan. 14, 2013). ...