Novartis said Friday that the European Commission approved Leqvio (inclisiran) for the treatment of adults with primary hypercholesterolaemia or mixed dyslipidaemia. The decision follows a recent positive opinion issued for the RNAi-based PCSK9 inhibitor, which is administered through twice-yearly dosing, by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).
Marie-France Tschudin, president of Novartis Pharmaceuticals, said the "first-in-class treatment [delivers] effective and sustained LDL-C reduction that has the potential to improve outcomes for people living with atherosclerotic cardiovascular disease." According to the approved indication, patients unable to reach their LDL-C goals on a maximally tolerated dose of statin, can take Leqvio as an added treatment, with or without other lipid-lowering therapies. Leqvio can also be prescribed either alone or in combination with other lipid-lowering therapies among those who cannot take statins due to intolerance or contraindications.
Novartis said the EU decision is based on results of the ORION clinical development programme, including the Phase III ORION-9, ORION-10 and ORION-11 studies, where Leqvio provided "effective and sustained" LDL-C reductions of up to 52%, despite patients being on maximally tolerated statin therapy. The company noted that with two doses a year, after an initial dose and one at three months, Leqvio is "expected to support long-term adherence."
Novartis acquired Leqvio via its $9.7-billion takeover of The Medicines Company, which was finalised early this year. Shortly after the buyout, Novartis struck a deal with England's national health service through which the drug could potentially be made broadly available for NHS patients as soon as 2021.
Meanwhile, the siRNA therapeutic is currently under review by the FDA for adults who have elevated LDL-C while being on a maximally tolerated dose of statin therapy.
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