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Find Clinical Drug Pipeline Developments & Deals for Inclisiran
Leqvio (inclisiran), the first and only approved small interfering RNA (siRNA) therapy to lower LDL-C, gains expanded approval for the treatment of adults with high LDL-C and who are at increased risk of heart disease.
Leqvio (Inclisiran) is the first and only small interfering RNA (siRNA) therapy to lower LDL-C. It is approved in over 80 countries, including the US, EU and China.
Leqvio (inclisiran), the first and only approved small interfering RNA (siRNA) therapy to lower LDL-C, gains expanded approval for the treatment of adults with high LDL-C and who are at increased risk of heart disease.
Leqvio is the first and only small interfering RNA (siRNA) therapy to lower LDL-C and is administered with 2 doses a year. Leqvio is important for ASCVD patients who are not reaching recommended LDL-C target levels despite taking other cholesterol-lowering medications.
LEQVIO (inclisiran) injection is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH).
The approval of Leqvio (Inclisiran) First siRNA is based on the ability of Leqvio to lower LDL cholesterol up to 52% in patients with Atherosclerotic Cardiovascular Disease.
Treatment emergent adverse events (TEAEs) at the injection site were more frequent with Leqvio, but all were mild or moderate. The effect of Leqvio on cardiovascular morbidity and mortality has not been determined.
Agreement follows positive NICE recommendation and commits to deliver Leqvio® (inclisiran) access via a population health management approach identifying eligible patients across England.
Separate post hoc analyses of pooled Phase III ORION-9, -10 and -11 data show twice-yearly Leqvio® (inclisiran) consistently reduced LDL-C in patients with atherosclerotic cardiovascular disease with established cerebrovascular disease and polyvascular disease.
The U.S. Food and Drug Administration (FDA) has not raised any concerns related to the efficacy or safety of inclisiran. The complete response letter is due to unresolved facility inspection-related conditions.
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