FDA Accepts Amgen's BLA For Evolocumab In High Cholesterol

By Cyndi Root

Amgen states that the Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for evolocumab. Amgen made the announcement in a press release, stating that the monoclonal antibody is for the treatment of high cholesterol. A decision is expected by the end of August, 2015.

Sean E. Harper, M.D., executive VP of Research and Development at Amgen, said, "There is still a large unmet need among patients with high cardiovascular risk and elevated cholesterol who are unable to reach optimal LDL cholesterol levels with current therapies. Evolocumab has the potential to provide significant additional benefit when added to existing LDL cholesterol-lowering medications for patients with high cholesterol."

Evolocumab

Evolocumab (AMG 145) is a fully human monoclonal antibody that inhibits a protein that prevents the body from clearing bad cholesterol, low-density lipoprotein cholesterol (LDL-C), from the blood. The protein, proprotein convertase subtilisin/kexin type 9 (PCSK9), reduces the liver's ability to remove LDLs. Elevated LDL-C is prevalent in dyslipidemia and can be responsible for cardiovascular events.

Amgen’s BLA submission for evolocumab contains data on approximately 6,800 patients from 10 Phase 3 trials. Participants included 4,500 patients with high cholesterol, patients on statin medications, patients who are intolerant of statin therapies, and other subgroups. The FDA granted evolocumab Orphan Drug status in 2013 for the treatment of homozygous familial hypercholesterolemia (HoFH).

Evolocumab Clinical Trial Program

Amgen’s clinical trial program for evolocumab is PROFICIO (Program to Reduce LDL-C and Cardiovascular Outcomes Following Inhibition of PCSK9 In Different Populations). The comprehensive program includes 35,000 patients in 22 trials. In the Phase 3 development program, 16 trials are evaluating dosing strategies in different subgroups. Amgen is trying evolocumab administration every two weeks or monthly. Other studies are evaluating safety and efficacy.

Amgen Activities

Recently, Amgen suffered a setback due to disappointing results from the TRINOVA-1 trial evaluating trebananib in women with recurrent ovarian cancer. The results showed that trebananib plus paclitaxel did not improve overall survival rates. In better news for the company, the FDA accepted Amgen’s BLA for BITE (bispecific T cell engager), an antibody construct of blinatumomab. The investigational treatment is for adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).