EU approves Leqvio for hypercholesterolemia.- Novartis

Novartis has announced that Leqvio (inclisiran) has been granted approval from the European Commission (EC) for the treatment of primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidaemia. Leqvio is indicated for use in populations characterised by elevated levels of cholesterol, as an adjunct to diet, in combination with a statin or alongside a statin with other lipid-lowering therapies. The drug can also be administered alone or in combination with other lipid-lowering therapies in patients who are statin intolerant.The marketing authorisation is based on results from the ORION clinical trial programme, which included results from the phase III trials ORION-9, ORION-10 and ORION-11, in which over 3,600 patients were enrolled.