The FDA has approved Novartis’ new drug for lowering bad cholesterol. Leqvio is the first and only siRNA treatment that can reduce low-density lipoprotein cholesterol.
The U.S. Food and Drug Administration (FDA) has approved the distribution and use of Novartis’ new drug for lowering bad cholesterol.
Leqvio (inclisiran) is the first and only small interfering RNA (siRNA) treatment that can reduce low-density lipoprotein cholesterol (LDL). It is intended as an adjunct to maximally tolerated statin therapy and a proper diet in adults diagnosed with heterozygous familial hypercholesterolemia (HeFH) and atherosclerotic cardiovascular disease, both of which need the lowering of LDL-C. Clinical trials are being planned to test Leqvio’s effect on cardiovascular morbidity and mortality.
The drug works by enhancing the liver’s natural ability to prevent the production of a type of protein that causes high cholesterol levels in the blood. It is recommended especially to patients who are having difficulty sticking to their self-administered treatments and medicines with high dosing frequencies. Leqvio is administered subcutaneously only two times a year, after an initial dose and another at the third month after.
The FDA’s decision is based on positive results from the Phase III ORION-9, -10, and -11 studies, which involved 3,457 participants who had either HeFH or ASCVD with elevated LDL-C and were undergoing statin therapy. On the 17th month, patients demonstrated an up to 52% reduction in LDL-C versus those who took a placebo.
The drug was also well-tolerated, with typical side effects including injection site reaction, diarrhea, urinary tract infection, chest cold, shortness of breath, and pain in the arms or legs. These side effects were consistent with those observed in the placebo group.
“As a first-of-its-kind siRNA therapy, Leqvio works differently than other cholesterol treatments, with twice-yearly dosing that makes it a compelling option for the millions of people with ASCVD already on cholesterol-lowering medications struggling to reach their LDL-C target,” said Dr. Normal Lepor, the clinical investigator in the Phase III trial for Leqvio, in a statement.
Novartis will develop, manufacture, and commercialize Leqvio through a deal with Alnylam Pharmaceuticals. The drug is expected to be out on the market in January 2022.
“Leqvio is a revolutionary approach to lower LDL-C, and creates new possibilities for how healthcare systems can impact cardiovascular disease, a defining public health challenge of our time,” commented Vas Narasimhan, the chief executive officer of Novartis, in the same statement.
Leqvio is not the only drug that Novartis has received FDA approval on recently. Today, the regulator approved using Cosentyx (secukinumab) in treating children and adolescents diagnosed with enthesitis-related arthritis and psoriatic arthritis. The drug is the only biologic therapy allowed for both ERA (children 4 years old and up) and PsA (children 2 years old and up).
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