FDA Approves Twice-Yearly Injection to Lower Cholesterol

Monitoring Desk

WASHINGTON: The Food and Drug Administration (FDA) recently approved a novel injectable cholesterol-lowering drug to be used as an adjunct to diet and statin medication. The Novartis drug, Leqvio, is the first small interfering RNA (siRNA) therapy to reduce LDL cholesterol, the low-density lipoprotein dubbed “bad” cholesterol because it can contribute to arterial blockage.

According to MedPage Today, Leqvio, generic name inclisiran, is injected subcutaneously, followed by a second shot at three months and then a maintenance dose every six months thereafter. The drug is geared for patients who have clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia who need to lower their levels of LDL.

Leqvio will be available in early January. European regulators already approved the siRNA at the end of 2020.

The most common side effects, according to MedPage, were mild-to-moderate injection site reaction, joint pain, urinary tract infection, diarrhea, chest cold, pain in the legs or arms, and shortness of breath. The clinical trials already performed did not determine whether or not the drug reduces death from cardiovascular disease. More studies are underway.

Approximately 16 million Americans with ASCVD taking statins to lower their cholesterol — including those who have already had a heart attack or stroke — are not at their recommended LDL target. According to Novartis, Leqvio provides effective and sustained reduction of LDL up to 52% versus a placebo for certain people with ASCVD who already take the maximum tolerated statin therapy.

“ASCVD is a substantial public health burden affecting 30 million Americans,” said Norman Lepor, a Los Angeles-based cardiologist, and a clinical investigator in the Phase III clinical program for Leqvio. “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 meet their LDL-C target.”

Courtesy: (Newsmax)