SWITZERLAND —In a significant stride towards combatting cardiovascular disease, a recent three-year follow-up trial has underscored the unwavering efficacy of Leqvio (inclisiran) when used alongside statin therapy.
The groundbreaking treatment showcases consistent reductions in low-density lipoprotein cholesterol (LDL-C), benefiting patients with atherosclerotic cardiovascular disease (ASCVD), heightened ASCVD risk, or heterozygous familial hypercholesterolemia (HeFH).
The three-year follow-up trial delving into Leqvio’s prowess sheds light on a notable advancement in cardiovascular treatment.
Developed as a collaboration between RNAi therapeutics firm Alnylam Pharmaceuticals and The Medicines Company (TMC) in 2013, Leqvio’s potential was further unlocked with its acquisition by Swiss pharmaceutical giant Novartis in 2020.
Leqvio’s role as a transformative adjunct to statin therapy becomes evident in its consistent LDL-C reduction benefits.
This therapy, available in injectable form, addresses individuals facing the dual challenges of ASCVD or HeFH and elevated LDL-C levels.
Administered through two maintenance doses annually, Leqvio is anchored in the innovative concept of utilizing small interfering RNA to target proprotein convertase subtilisin-kexin type 9 (PCSK9) messenger RNA.
Trial insights and results
The ORION-8 trial, an open-label extension of several previous ORION trials, brought together 3274 participants who faced ASCVD, heightened ASCVD risk, HeFH, and elevated LDL-C levels.
Over the course of up to three additional years, patients received regular inclisiran doses.
The outcomes unveiled a notable achievement: 78.4% of participants reached their pre-defined LDL-C targets, marking a significant step towards cardiovascular health.
The reduction in average LDL-C levels stood at 49.4%, reinforcing the treatment’s consistent benefits. Moreover, the trial’s safety data echoed previous inclisiran findings, highlighting its safety profile.
Addressing a pervasive health concern
Atherosclerosis, characterized by lipid accumulation within arteries, is a major contributor to cardiovascular disease.
Leqvio’s impact on reducing LDL-C levels emerges as a crucial solution for countering this ailment, which accounts for over 85% of cardiovascular disease-related deaths and holds the ignominious title of being the leading cause of mortality in the EU.
David Soergel, MD, Novartis’ Global Head of Cardiovascular, Renal and Metabolic Drug Development said, “The trial is part of a growing body of evidence for Leqvio being generated through our ongoing VictORION program that is examining the use of Leqvio in broad and varied patient populations affected by ASCVD.”
Furthermore, Leqvio’s expanding horizons reflect its significance in the healthcare landscape. The treatment’s label was recently extended to encompass adults with primary hyperlipidemia, fortifying its status as a versatile adjunct to dietary and statin-based interventions.
This breakthrough approach even garnered a landmark agreement with the UK’s National Health Service, ensuring wider accessibility to eligible patients.
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