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.