ZURICH: Novartis said on Friday it received approval from the European Commission for Leqvio, also known as inclisiran, a drug to lower cholesterol that the Swiss drugmaker bought last year in a deal worth nearly US$10 billion and expects to be a top seller.
Leqvio was approved for the treatment of adults with hypercholesterolemia or mixed dyslipidemia, making it the first and only approved small-interfering RNA (siRNA) low-density lipoprotein cholesterol (LDL-C) lowering treatment in Europe, Novartis said in a statement.
“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,” Marie-France Tschudin, president of Novartis Pharmaceuticals, was quoted as saying in the statement.
Novartis bought the treatment last year in its US$9.7 billion takeover of The Medicines Co in a bid to challenge cardiovascular medicines from Amgen Inc, Sanofi and Regeneron Pharmaceuticals.
Leqvio, for use on top of statins by heart patients who struggle to lower their cholesterol levels with traditional therapy, complements Novartis’ business with its heart-failure medicine Entresto.
Leqvio is currently under review by the US Food and Drug Administration and other health authorities, Novartis said.