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FDA Approves First-in-Class Therapy to Lower LDL Cholesterol
Leqvio (inclisiran) is the first small interfering RNA therapy approved to lower LDL cholesterol in certain adults at risk for life-threatening cardiovascular events.
The FDA has approved Leqvio (inclisiran) injection to be used in conjunction with diet and maximally tolerated statin therapy to lower LDL cholesterol in adults with familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL cholesterol. HeFH is a hereditary gene mutation that interferes with a person’s ability to clear cholesterol. Patients with HeFH typically have LDL cholesterol levels at least twice as high as normal levels and have an increased risk of cardiovascular events, such as stroke, coronary artery disease, and heart attack. ASCVD refers to cholesterol plaque buildup in arteries, which can lead to life-threatening events, such as heart attack, stroke, and peripheral artery disease.
Related: Novartis Resubmits Application for Inclisiran
Leqvio (pronounced leck-vee-oh), which was developed by Novartis, is the first small interfering RNA (siRNA) therapy FDA-approved to lower LDL cholesterol. It interferes with RNA in hepatocytes to decrease the production of PCSK9, a protein that can increase circulating LDL levels. As a result of decreased PCSK9 production, Leqvio helps lower LDL cholesterol levels.
Leqvio is injected subcutaneously every six months after giving two loading doses three months apart.
Three randomized, double-blinded, placebo-controlled clinical trials studied the effectiveness of Leqvio in over 3,000 adults with HeFH or clinical ASCVD who were taking maximally tolerated statin therapy and required additional lowering of LDL cholesterol. The effectiveness of Leqvio was assessed by measuring the percentage change in LDL cholesterol levels after 17 months of treatment. In Study 1, patients taking Leqvio had an average of 51% decrease in LDL levels. Patients in the Leqvio group in Study 2 had an average of 46% decrease in LDL levels. In Study 3, patients taking Leqvio had an average of 40% decrease in LDL cholesterol levels. In all three trials, patients in the placebo group saw an increase in LDL cholesterol levels between 1% and 8%.
Related: ICER Chief on Bempedoic Acid and Inclisiran: Don’t Repeat the PCSK9 Mistake
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
