New Rx May Lower Cholesterol in 2 Doses Per Year

FDA approves first-in-class drug Leqvio (inclisiran) to lower cholesterol

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new medication to lower cholesterol in just two doses per year.

The drug is called Leqvio (inclisiran). The FDA approved it for use in conjunction with statins to help reduce LDL ("bad") cholesterol levels.

Leqvio is the first in a class of drugs called small interfering RNA (siRNA) therapy to be approved for use in LDL cholesterol reduction. This new approval also stands out because of the dosage frequency. After an initial injection and a follow-up injection three months later, Leqvio is administered only twice per year after that.

According to the maker of the drug, Leqvio works by stopping RNA that is involved in the production of substances that regulate cholesterol absorption.

This new medication was studied in three large trials before its FDA approval. In those trials, patients who had certain types of cardiovascular disease or high cholesterol saw reductions of more than 50 percent in their LDL cholesterol levels over one or two years.

Officials with Novartis, the maker of Leqvio, said they had high hopes for the drug's impact on Americans with high cholesterol and heart disease.

“Leqvio is a revolutionary approach to lower LDL-[cholesterol], and creates new possibilities for how healthcare systems can impact cardiovascular disease, a defining public health challenge of our time,” said Vas Narasimhan, Novartis CEO, in a press release. “We now have the opportunity, working together with partners, to provide this first-ever approved LDL-[cholesterol]–lowering siRNA-based therapy to tackle [atherosclerotic cardiovascular disease] at scale across the United States.”

Common side effects of Leqvio included joint pain, diarrhea, pain in the legs or arms, urinary tract infection, chest cold, shortness of breath, and rash, redness and pain at the injection site.

If you have high cholesterol or heart disease related to high cholesterol, ask your health care provider about the best cholesterol-lowering medications for you.

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Review Date: 
December 30, 2021