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The Food and Drug Administration (FDA) has updated the indication for Leqvio® (inclisiran) to include treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce low-density lipoprotein cholesterol (LDL-C), as an adjunct to diet and statin therapy.
Leqvio is a chemically synthesized small interfering RNA that targets proprotein convertase subtilisin-kexin type 9 (PCSK9) messenger RNA. Leqvio, in combination with statin therapy, is administered as an initial single subcutaneous injection, with a second dose at 3 months, and continued treatment once every 6 months.
Previously, Leqvio had only been approved for patients with HeFH or clinical atherosclerotic cardiovascular disease (ASCVD). The expanded approval now includes patients with comorbidities (eg, hypertension or diabetes) who have not yet had a first cardiovascular event.
Additional changes to the labeling include the removal of the Limitations of Use statement (“The effect of Leqvio on cardiovascular morbidity and mortality has not been determined”), as well as 4 adverse events (urinary tract infection, diarrhea, pain in extremity, dyspnea) from the safety section because the frequency of these events was found to be similar to placebo.
Leqvio is supplied as a 284mg/1.5mL (189mg/mL) injection in a single-dose prefilled syringe.
