The FDA approved inclisiran (Leqvio) injection as an adjunct to diet and maximally tolerated statin therapy for the treatment of heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) in adults who require additional lowering of low-density lipoprotein cholesterol (LDL-C).
Inclisiran is administered in combination with maximally tolerated statin therapy as an initial single 284-mg subcutaneous injection, with a second dose at 3 months and continued treatment once every 6 months.
The FDA approved inclisiran based on data from three clinical trials conducted in over 3,450 adults with HeFH or ASCVD. The percentage changes in LDL-C from the beginning of each trial to day 510 were as follows:
- Study 1: 51% in the inclisiran group vs 1% in the placebo group
- Study 2: 46% in the inclisiran group vs 4% in the placebo group
- Study 3: 40% in the inclisiran group vs 8% in the placebo group
The effect of inclisiran on cardiovascular morbidity and mortality has not been determined.
Common side effects of inclisiran in the trials included injection site reactions, joint stiffness, urinary tract infection, diarrhea, bronchitis, pain in extremity, and difficulty breathing.
Inclisiran is a product of Novartis. Consult labeling for full prescribing information.
