Novartis on Tuesday announced Leqvio provides effective low-density lipoprotein cholesterol (LDL-C) reduction over a four-year period in patients with either atherosclerotic cardiovascular disease (ASCVD).
ASCVD is a condition that causes arteries to narrow, restricting healthy blood flow to organs as well as the arms and legs. Studies suggest that when ASCVD blocks blood flow to the heart or brain, it can lead to heart attack and strokes.
The drug maker announced the results from the Phase II open-label extension ORION-3 trial. According to the company, Leqvio is the first and only small interfering RNA (siRNA) therapy to lower LDL-C and is administered with two doses a year. Results were presented at the American Heart Association (AHA) Scientific Sessions 20221.
“The results we’ve seen in patients after four years of treatment demonstrate that inclisiran is well-tolerated and can help patients achieve LDL-C reduction while also maintaining and sustaining their levels. Still too many patients are struggling to reach their LDL-C target levels. A therapy that provides sustained LDL-C reduction with a twice-yearly maintenance dosing schedule may be a turning point in the treatment of ASCVD,” said Kausik Ray, M.D., Professor of Public Health in the Department of Public Health and Primary Care at Imperial College London and Honorary Consultant Cardiologist at the Imperial College NHS Trust.
“In ORION-3, an open-label extension of Phase II ORION-1 trial, LDL-C level reduction was sustained over the four-year study period: patients treated with Leqvio achieved an average 47.5 percent reduction in LDL-C from baseline (Day 1 of ORION-1) to Day 210 (95 percent Cl:-50.69,-44.27) and a time-averaged reduction in LDL-C of 44.2 percent over the four years through twice-yearly dosing,” the company said in a statement on Tuesday.
The company claims that ORION-3 provides the longest safety follow-up in a Leqvio study to date. After four years of therapy, Leqvio was well-tolerated, with a safety profile consistent with previous 18-month Phase III LDL-C lowering studies.
“Patients with ASCVD are a large, high-risk population in the US, and a majority are not achieving their LDL-C target levels. The sustained benefit of a twice-yearly treatment is a major advance in meeting the needs of these patients,” said Norman Lepor, M.D., a Los Angeles based cardiologist and Director of the National Heart Institute in a statement.