Novartis Gains EU Approval for Leqvio
Novartis has won approval from the European Commission for Leqvio (inclisiran), a potential blockbuster cholesterol drug for treating adults with hypercholesterolemia or mixed dyslipidemia.
Approval was supported by positive phase 3 results indicating the drug reduced low-density lipoprotein cholesterol (LDL-C) by up to 52 percent in patients with elevated levels.
The drug is a small interfering RNA treatment meant for patients with atherosclerotic cardiovascular disease who require LDL-C reduction. The Swiss drugmaker said the drug is meant to be given twice a year as a long-term treatment.
The FDA is currently reviewing an NDA for Leqvio for the treatment of adults with high levels of LDL-C and is expected to make a decision by year’s end.