BioCentury
ARTICLE | Clinical News

Tredaptive regulatory update

January 14, 2013 8:00 AM UTC

Merck said it will suspend the worldwide availability of Tredaptive after data from the investigator-led Phase III HPS2-THRIVE trial showed 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 pharma recommended that physicians stop prescribing Tredaptive and review treatment plans for patients who are receiving the drug. Separately, EMA's Pharmacovigilance Risk Assessment Committee recommended suspending marketing authorization of Tredaptive in the EU; a final decision from EMA's CHMP is expected this month. EMA began the review of Tredaptive in December following the HPS2-THRIVE data (see BioCentury, Dec. 24, 2012). ...