Amgen’s Phase III Evolocumab Trial Meets Endpoints

Amgen’s Phase III GAUSS-2 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-2) trial of evolocumab in patients with high cholesterol who can’t tolerate statins, met its co-primary endpoints: the percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C), and the mean percent reduction from baseline in LDL-C.
 
Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver’s ability to remove LDL-C from the blood. Safety was generally balanced across treatment groups and the most common adverse events were headache, myalgia, pain in extremity, and muscle spasms.