FRANCE — The US Food and Drug Administration (FDA) has granted approval for a label update on Leqvio (inclisiran) as an adjunct treatment, in combination with diet and statins, for patients diagnosed with primary hyperlipidemia.

This patient population encompasses individuals without a history of cardiovascular events but with comorbidities such as hypertension and diabetes.

Primary hyperlipidemia is characterized by elevated levels of low-density lipoprotein cholesterol (LDL-C), which can accumulate in arterial linings, forming plaques.

These plaques have the potential to rupture, leading to severe consequences like heart attacks or strokes.

Victor Bulto, President of Novartis Innovative Medicines US, emphasized the significance of reducing high LDL cholesterol as a modifiable risk factor for heart disease.

He expressed his belief that the label update for Leqvio will extend the treatment’s reach to a larger number of patients struggling to lower their LDL cholesterol levels.

Initially, Leqvio received FDA approval in 2021 as an additional therapy, alongside maximally tolerated statins, for patients with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require further reduction of LDL cholesterol.

GlobalData, a leading data and analytics company, has projected Leqvio’s global sales to surpass US$2.9 billion due to its favorable reimbursement options, semi-annual dosage regimen, and professional administration.

Priced at approximately US$6,500 per year, Leqvio’s cost is comparable to competitors such as Sanofi/Regeneron’s Repatha (evolocumab) and Amgen’s Praluent (alirocumab).

In the UK, Leqvio is available at a discounted price under a commercial agreement with the National Health Service (NHS).

Notably, the label update eliminates the “limitations of use” statement, while four adverse events have been removed from the safety section.

Novartis made this adjustment based on the findings that the frequency of these events was similar to the placebo arm in the VictORION clinical trial program, which involved over 60,000 patients across 27 trials worldwide.

Earlier this year, Novartis terminated a large-scale UK study investigating Leqvio for primary prevention purposes.

Novartis acquired Leqvio through its acquisition of The Medicines Company in 2020 for US$9.7 billion. The treatment was initially developed by Alnylam Pharmaceuticals.

As part of a strategic collaboration between Alnylam and Blackstone private equity investors, 50% of Alnylam’s Leqvio-related royalties will be directed to Blackstone.

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