By Estel Grace Masangkay
A report from the Decision Resources Group gives the gold medal to Amgen’s evolocumab in the race among statin add-on therapies for dyslipidemia in its report Dyslipidemia (in statin-treated patients): Do Physicians Have High Hopes for LDL-lowering Therapies in Cardiovascular Outcomes?
Evolocumab is a fully human monoclonal antibody that works to inhibit proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 protein is implicated in the degradation of LDL receptors and therefore lessens the liver’s ability to remove LDL-C, more commonly known as bad cholesterol, from the blood. Evolocumab binds to PCSK9 to increase the amount of LDL receptors on the liver’s surface.
Amgen’s drug leads the race among investigational PCSK9 inhibitors, DRG reports, thanks to its highly effective LDL-C lowering mechanism and potential to cut down risk of cardiovascular disease.
According to DRG’s report, a drug’s ability to reduce rate of cardiovascular mortality weighs heavily on U.S. and European primary care physicians’ (PCP) decision in prescribing drugs for patients with dyslipidemia. PCPs also underlined the rate of cardiovascular morbidity as an area of major unmet need in in-statin treated patients.
DRG Research Associate Stefanie Hoffart, said, “Although thought leaders and the new U.S. blood cholesterol guidelines highlight a shift more towards prevention of cardiovascular events over targeting specific lipid levels, the need for additional lipid-lowering treatment when the risk of cardiovascular disease remains clinically significant is still widely recognized.”
Among the emerging therapies discussed in the report were Amgen’s evolocumab, AstraZeneca’s epanova, and Pfizer’s bococizumab. Pfizer reported promising results for bococizumab from a Phase IIB study last March. In April, collaborators Sanofi and Regeneron also posted positive results for PCSK9 inhibitor alirocumab from their Phase II study in Japanese patients.
In the recent annual meeting of the American College of Cardiology (ACC), Amgen presented positive data from five clinical studies of evolocumab showing that the drug achieved a 55 percent to 66 percent reduction in LDL compared to placebo. Last month the company shared new data from the Phase III TESLA and Phase II/III TAUSSIG studies at the 82nd Congress of the European Atherosclerosis Society (EAS 2014).