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On 3 October the Italian Medicines Agency (Aifa) has approved the reimbursement of Inclisirandrug produced by the biotech company Novartis for the treatment of primary hypercholesterolemia e of the mixed dyslipidemia (conditions characterized by high levels of fat in the blood). This is the first innovative anti-cholesterol therapy to act through the interference of the rnaa technology that uses small molecules of rna to inhibit training of the so-called cholesterol “bad“, by directly blocking genes that increase blood levels. The drug, which in clinical trials has been shown to halve the amount of cholesterol compared to placebo, is prescribed by medical specialists and is administered via two subcutaneous injections a year.
The risks of “bad” cholesterol
The cholesterol it is a lipid molecule produced by the liver and in the body it fulfills several essential functions, from the production of vitamin D to guaranteeing the integrity of biological membranes; however, a excess cholesterolwhether due to genetic predisposition, lifestyle or a combination of the two, can be harmful to the body, favoring, as reports the Higher Institute of Health, the occurrence of cardiovascular diseases. In particular, these processes seem to be involved proteins that carry cholesterol in the bloodespecially the so-called low density lipoprotein (also known by the acronym ldl) which have the function of distributing cholesterol from the blood to all organs of the body. If the cholesterol levels associated with ldl proteins are too high, in fact, it can encourage the development of conditions such as atherosclerosis, which contributes to the development of cardiovascular diseases. Precisely for this reason, LDL cholesterol is called “bad” cholesterol.
How it works and how it is administered
Generally, in addition to lifestyle changes, hypercholesterolemia is treated with administration of statinsdrugs capable of blocking an enzyme involved in the body’s production of cholesterol, thereby also reducing it ldl cholesterol levels. The new drug manufactured by Novartis, whose trade name is Leqvio, on the other hand, works with a different principle: through small molecules of rna it blocks the pcsk9 gene, a protein that raises ldl cholesterol levels; pcsk9, in fact, has the purpose of degrading a receptor that stores ldl cholesterol inside the cells, removing it from the blood. By preventing the production of this protein (and consequently increasing the presence of “scavenger” receptors on the cell surface), therefore, the drug is able to reduce LDL cholesterol levels in the blood.
All this is possible thanks to the RNA interference technologynatural biological mechanism present in cells that It “silences” the genes through – precisely – small molecules of rna; the latter, which for this reason are called “interferers”, by binding in a highly specific manner to the messenger RNA sequences of the target gene, block the production of the corresponding proteins. Due to its efficiency and specificity this mechanism was used for it development of numerous therapies for viral infections, neurological disorders and many types of cancers.
Compared to statins, the new anti-cholesterol drug also shows an innovation in the methods of administration: in fact, it is administered, in association with a low-fat diet, by means of subcutaneous injection (usually in the belly, upper arm or thigh). After the first injection, patients receive the next dose after three months and then every six months.
What the clinical studies say
In accordance to reported by the European Medicines Agency (Ema), three clinical trialsconducted on over 3600 patients with high levels of LDL cholesterol, with atherosclerosis or with the risk of developing it, they demonstrated effectiveness by Inclisiran, which lowered cholesterol levels more than statins or other medicines used to lower blood lipids. In particular, after one year and three months of taking, in fact, in patients treated with the new drug LDL cholesterol had dropped by more than 50% compared to those who took the placebo. Among the most common side effects recorded were local reactions at the injection site, such as pain, redness and rashes.
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