GSK’s Cardio Drug Darapladib Fails Late-Stage TestBy
GlaxoSmithKline (GSK) reported disappointing results for its late-stage cardiovascular drug candidate, darapladib, an Lp-PLA2 (lipoprotein-associated phospholipase A2) inhibitor currently being investigated as a potential agent for reducing cardiovascular events in patients with coronary heart disease, saying that the results do not support a regulatory submission in atherosclerosis.
Darapladib is not approved for use anywhere in the world yet, and in this second Phase III study, darapladib did not achieve the primary endpoint of a reduction of major coronary events versus placebo when added to standard of care. In November 2013, GSK announced results of the first Phase III study, which showed that darapladib did not achieve a statistically significant reduction in the primary endpoint of major adverse cardiovascular events (comprised of cardiovascular death, myocardial infarction and stroke) versus placebo.
Patrick Vallance, GSK's President of Pharmaceuticals R&D, commented: “We are disappointed that the outcome of this second Phase III study with darapladib does not support a regulatory submission in atherosclerosis,” he said in a GSK press release. “We will now work to further analyze the data and better understand the findings.”