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news.Novartis has secured approval from the European Commission (EC) for its Leqvio (inclisiran) to treat adults with hypercholesterolemia or mixed dyslipidemia.
Novartis has secured EC approval for Leqvio to treat hypercholesterolemia or mixed dyslipidemia. (Credit: Novartis AG)
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Leqvio, a first-in-class small interfering RNA (siRNA), has been approved based on data from the ORION clinical development programme.
The approval allows to use Leqvio in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach low-density lipoprotein cholesterol (LDL-C) goals with the maximally tolerated dose of a statin or alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
ORION-9 was a pivotal phase III, placebo-controlled, double-blind and randomised study that assessed the efficacy, safety and tolerability of inclisiran sodium salt 300mg, equivalent to 284mg of inclisiran.
ORION-10 was a pivotal phase III, placebo-controlled, double-blind and randomised study that assessed the efficacy, safety and tolerability of inclisiran sodium salt 300mg, equivalent to 284mg of inclisiran.
ORION-11 was a pivotal phase III, placebo-controlled, double-blind and randomised study that evaluated the efficacy, safety and tolerability of inclisiran sodium salt 300mg, equivalent to 284mg of inclisiran. All doses are administered subcutaneously by a healthcare professional.
According to the company, Leqvio provided an effective and sustained low-density lipoprotein cholesterol (LDL-C) reduction of up to 52% in patients with elevated LDL-C in the ORION clinical development programme.
Novartis has secured global rights to develop, manufacture and commercialise Leqvio, as part of a licence and collaboration agreement with Alnylam Pharmaceuticals.
Novartis Pharmaceuticals president Marie-France Tschudin said: “Cardiovascular disease remains the leading cause of mortality in Europe, which demonstrates the urgent need for innovative treatments for patients struggling to reach their LDL-C goals.
“With Leqvio, we’re proud to bring a first-in-class treatment delivering effective and sustained LDL-C reduction that has the potential to improve outcomes for people living with ASCVD.”
In November this year, Novartis secured EC approval for its Adakveo (crizanlizumab) to prevent recurrent vaso-occlusive crises (VOCs) or pain crises in patients with sickle cell disease aged 16 years and older.
