Novartis new analysis further shows durable and potent LDL-C reduction with inclisiran, an investigational first-in-class siRNA cholesterol-lowering treatment - Seite 2

“There remains a compelling need for new and novel LDL-C-lowering therapies given the residual risk faced by many patients with atherosclerotic cardiovascular disease and the inability of oral lipid-lowering therapy alone to achieve important LDL targets,” said ORION-10 principal investigator R. Scott Wright, M.D., Professor of Medicine, Consultant in Cardiology, Mayo Clinic in Rochester, Minnesota. “Inclisiran harnesses the body’s natural mechanisms for RNA silencing and lowers LDL-C. This analysis confirms that twice-yearly dosing of inclisiran achieves durable and potent reductions in LDL-C in the phase III studies.”

“The results presented reinforce our belief that inclisiran has the potential to be the first small interfering RNA (siRNA) agent to help patients get their LDL-C to desired levels,” said John Tsai, Head of Global Drug Development and Chief Medical Officer, Novartis. “The unique twice yearly dosing fits easily into regular physician appointments and could help reimagine how we lower and control LDL-C for patients.”

Inclisiran is currently under review by the the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for use in adults with ASCVD or heterozygous familial hypercholesterolemia (HeFH) who have elevated LDL-C while being on a maximum tolerated dose of a LLT. Inclisiran is administered subcutaneously with an initial dose, again at 3 months and then every 6 months, offering a unique dosing regimen. If approved, inclisiran will be the first and only LDL-C-lowering treatment in the siRNA class.

Hyperlipidemia refers to the high level of lipids (fats, cholesterol, triglycerides), such as LDL-C, found in the blood that are either acquired or from genetic disorders³. LDL-C is the most readily modifiable risk factor for ASCVD^4-9.  Despite the widespread use of therapies to reduce LDL-C, the majority of patients do not reach guideline-recommended treatment goals, leaving them at continued risk of a life-threatening condition¹⁰.

About the pooled analysis
The pooled analysis includes data from inclisiran’s ORION-9, -10 and -11 trials, which are multicenter, double-blind, randomized, placebo-controlled, 18-month studies evaluating inclisiran in patients with heterozygous familial hypercholesterolemia (ORION-9), ASCVD (ORION-10) and ASCVD or ASCVD risk equivalents (ORION-11). The primary endpoints for these studies were percentage change in LDL-C from baseline to 17 months and time-adjusted percentage change in LDL-C from baseline between 3 months and up to 18 months. The primary endpoints were achieved in all three studies. The prespecified analysis of pooled data assessed inclisiran’s efficacy for lowering of LDL-C and other lipids/lipoproteins, as well as safety and tolerability, across these studies¹.