Novartis Boosts Access to Cholesterol-Lowering RNA Therapy

Novartis and NHS England recently reached a commercial agreement to enable broad access to Novartis’ RNA therapy, Leqvio, which helps lower LDL cholesterol (LDL-C) in eligible patients with atherosclerotic cardiovascular disease (ASCVD). 

The agreement follows a final recommendation from the National Institute for Health and Care Excellence (NICE) for Leqvio to treat adult patients within its licensed indication who have persistently elevated LCL-C levels and a history of certain cardiovascular events.

Leqvio is the first and only small interfering ribonucleic acid (siRNA) therapy to reduce LDL-C levels via an RNA interference (RNAi), a Novartis spokesperson explained.

The NICE based its recommendation on positive results from the Novartis ORION clinical research program, which enrolled over 3,600 patients to assess the safety, efficacy, and tolerability of Leqvio in lowering LDL-C levels. 

In the trials, Leqvio helped sustain LDL-C reduction of up to 52 percent in patients with elevated LDL-C.

“I see many patients where their cholesterol levels are insufficiently controlled for their level of risk, often despite optimal use of available therapies, putting them at increased risk of a heart attack or stroke,” Kausik Ray, MD, professor of public health at Imperial College London and honorary consultant cardiologist at the Imperial College NHS Trust, said in the announcement. 

“Having faster and broader access to a medicine like Leqvio, which offers the combination of a convenient twice-a-year maintenance dosing schedule, as well as the ability to be used in primary care and provide sustained reductions in LDL-C is a hugely positive milestone in patient care,” Ray continued. 

High cholesterol is a major cause of cardiovascular disease. About 7.6 million individuals across the UK live with heart and circulatory diseases, which cause over a quarter (27 percent) of all deaths each year. 

Leqvio works simultaneously with maximally-tolerated statins and a lipid-lowering diet to prevent the production of the target protein in the liver, increasing uptake of LDL-C and clearing it from the bloodstream.

Under the collaboration, Novartis will work with the NHS Accelerated Access Collaborative and the Academic Health Science Network to proactively identify, treat, and monitor eligible patients with ASCVD.

“HEART UK looks forward to continuing our leading role in helping people effectively manage their cholesterol and we warmly welcome the collaboration between Novartis and the NHS to enable more people to access this innovative medicine,” said Jules Payne, head of the cholesterol charity HEART UK.