Amgen’s Evolocumab Meets Primary Endpoints in Phase III

▲Click for full story

“Amgen’s heart drug evolocumab met its primary endpoints of percent reduction from baseline LDL cholesterol at week 12 and mean percent reduction from baseline low-density lipoprotein (LDL) cholesterol at weeks 10 and 12 in the Phase III LAPLACE-2 study, Amgen said Tuesday.

The randomized, double-blind trial evaluated the PCSK9 inhibitor’s safety, tolerability and efficacy in combination with five statins and as compared to placebo and Merck’s ezetimibe. The drug was analyzed in 1,896 adult patients with high cholesterol at 244 sites across the globe.  Results are consistent with those seen in Phase II trials evaluating evolocumab against placebo and ezetimibe, respectively, in which evolocumab combined with standard of care lowered LDL at a rate up to 66 percent without showing increased adverse events.”

***

From FDA

Advertisements