Novartis announced four-year results from its Phase III extension trial of Leqvio (inclisiran) showing an average decrease of 50% in low-density lipoprotein cholesterol (LDL-C) in about 80% of the patients with cardiac diseases.
The data was presented at the European Society of Cardiology (ESC) Congress 2023 in Amsterdam on 28 August.
Leqvio is a small interfering RNA (RNAi) therapy that is administered twice a year in addition to the standard statin therapy. Novartis acquired the global development, manufacturing and marketing rights to the drug in 2019 as part of The Medicine Company acquisition.
Leqvio has been approved in several countries, including the US, Europe and China, for the treatment of ASCVD and HeFH. Recently, the US Food and Drug Administration (FDA) approved Leqvio as an adjunct treatment with diet and statins for patients with primary hyperlipidaemia.
Novartis reported $78m in sales for Leqvio in Q2 of 2023, as per the company’s Q2 financial report. GlobalData estimates Leqvio sales to increase steadily with the drug generating over $2.9bn in global sales in 2029. The high estimate is based on its $6,500-a-year price tag, ease of reimbursement, and twice-a-year dosage.
GlobalData is the parent company of Clinical Trials Arena.
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Phase III trial data
The open-label, multicentre Phase III trial (NCT03814187) enrolled 3,274 patients who have either atherosclerotic cardiovascular disease (ASCVD), increased risk of ASCVD or heterozygous familial hypercholesterolaemia (HeFH) and had previously participated in Leqvio trials (ORION-10: NCT03399370, ORION-11: NCT03400800; ORION-3: NCT03060577; and ORION-9: NCT03397121).
The trial met its primary endpoint of achieving the LDL-C target range in the patients. The LDL-C target range was set at less than 70mg/dL for patients with ASCVD and less than 100mg/dL for patients with increased risk of ASCVD. Approximately 80% of patients reached these pre-specified LDL-C targets, with an average reduction in the LDL-C levels of 50%.
No new adverse events for Leqvio were observed in the trial. Additionally, 5.9% of the patients reported injection site adverse events with Leqvio, compared to 8% of patients reporting these events in the pooled analysis of the Leqvio arm of ORION-9, ORION-10, and ORION-11 trials.
“The ORION-8 results affirm the benefits of Leqvio in helping patients achieve sustained LDLC reduction, which is important as cumulative exposure to LDL-C leads to the growth of plaque in the arteries and an increased risk of cardiovascular events,” said David Soergel, global head of cardiovascular, renal and metabolic drug development at Novartis in a press release.
“The trial is part of a growing body of evidence for Leqvio being generated through our ongoing VictORION programme that is examining the use of Leqvio in broad and varied patient populations affected by ASCVD.”