Amgen announces positive top-line results from Phase 3 TESLA trial of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia; study meets primary endpoint of LDL cholesterol reduction (122.54)
Co announced that the Phase 3 TESLA (Trial Evaluating PCSK9 Antibody in Subjects with LDL Receptor Abnormalities) trial evaluating evolocumab met its primary endpoint of the percent reduction from baseline at week 12 in low-density lipoprotein cholesterol (LDL-C). The percent reduction in LDL-C, or "bad" cholesterol, was clinically meaningful and statistically significant. 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. The most common adverse events in the evolocumab group (more than one subject) were upper respiratory tract infection, influenza, gastroenteritis and nasopharyngitis.
Details of the Phase 3 TESLA trial will be submitted to a future medical conference and for publication.
If the price for the AMGN product is about $20 to $40K there is a chance that many insurances will have patients show that they fail this product first, then they can get the honor of paying $350K for a twenty year old drug. t