Novartis’ cholesterol med Leqvio wins EU approval

Swiss pharma company Novartis’ cholesterol-lowering drug 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 has been indicated for use in these populations, which are both 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.

Following the EC approval and upon further approval from the UK’s National Institute for Health and Care Excellence (NICE), Novartis and the NHS will make the medicine available through a population-level agreement to reduce the risk of heart disease.

Novartis and the NHS signed a deal back in January to provide the drug to secondary prevention atherosclerotic CVD patients, in a bid to save up to 30,000 lives over the next decade.

According to Novartis, heart and circulatory diseases cause over a quarter of all deaths each year in the UK, with 7.4 million people currently living with these diseases day-to-day.

“As the first and only treatment of its kind, Leqvio embodies our commitment to develop innovative therapies that expand the frontiers of cardiovascular medicine,” said Chinmay Bhatt, managing director UK, Ireland & Nordics for Novartis Pharmaceuticals.

“I am confident that our pioneering and ongoing collaboration with NHS England could help ensure the benefits of this innovation can truly be realised for hundreds of thousands of patients across the UK,” he added.

The EC marketing authorisation was based on results from Novartis’ ORION clinical research programme, which includes results from the phase 3 trials ORION-9, ORION-10 and ORION-11, which involved over 3,600 patients.