FDA Approves Novartis’ Cholesterol Drug Leqvio

FDA has approved Novartis’ Leqvio (inclisiran) injection as a treatment to be used with diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of low-density lipoprotein cholesterol. An agency statement says Leqvio is approved at a 284 mg dose administered as an initial under-the-skin injection, a second dose at three months, and continued treatment once every six months after that.

Leqvio’s effectiveness was studied in three trials that enrolled 3,457 subjects with either of the diseases in the indication. The effect of the drug on cardiovascular morbidity and mortality has not been determined.

Common Leqvio side effects include injection site reaction, joint stiffness, urinary tract infection, diarrhea, bronchitis, pain in extremity, and difficulty breathing.