Amgen announced that the Phase 3 TESLA trial met its primary endpoint of the percent reduction from baseline at Week 12 in low-density lipoprotein cholesterol (LDL-C). Evolocumab is an investigational fully human monoclonal antibody that inhibits protein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver’s ability to remove LDL-C from the blood.
TESLA (Trial Evaluating PCSK9 Antibody in Subjects with LDL Receptor Abnormalities) is a two-part Phase 2/3 trial that evaluated evolocumab in patients with homozygous familial hypercholesterolemia (HoFH) in adult and adolescent patients (n=49) who were on a stable statin dose and other lipid-lowering medication. Patients were randomized to evolocumab 420mg SC monthly or placebo SC monthly. Evolocumab demonstrated a clinically meaningful and statistically significant reduction ion LDL-C.
Details of the Phase 3 TESLA trial will be submitted for publication.
For more information call (800) 772-6436 or visit Amgen.com.