A brand new drug that was created to treat heart disease is being called “life changing,” and is now approved from use in the United Kingdom. Alongside the National Health Service (NHS) of England and Wales, Novartis, which is the manufacturer of the medication, has struck a deal to begin selling the shot at a reduced price.
Their decision was made after a global trial demonstrated that the medicine can “safely cut cholesterol by 50%.” The plan is to give 300,000 doses of the drug to those that need it, which translates to 30,000 individuals possibly escaping early death because of strokes and heart attacks.
Statistics have shown that half of the United Kingdom’s adult population have cholesterol levels that are considered above the national guidelines, while almost 8 million people nationwide are taking lipid-lowering drugs to lower their cholesterol levels.
With this new drug, it could be considered a “game changer” considering it can possibly prevent around 55,000 heart attacks and strokes throughout the United Kingdom, which could save over 30,000 lives in the next decade or so.
This revolutionary medication is called inclisiran, which is administered to patients in injection form. What it does is boost the liver’s ability to lessen their levels of low-density lipoprotein (LDL) cholesterol, which is otherwise known as “bad” cholesterol.
How Does LDL Cholesterol Work in the Body?
When someone suffers from too much LDL cholesterol, it causes the fatty deposits known as plaques, to build up in the blood vessels.
In time, these tiny deposits get bigger, limiting the oxygen-rich blood flow to the heart. They also have the ability to break off and clog the blood arteries, as well as make them less flexible as well.
When the plaques end up cutting off the blood flow to the heart, it can cause a heart attack. When it happens in the arteries that lead to the brain, it can cause a stroke to occur.
The announcement of the approval of the use of inclisiran in England and Wales, which came on Wednesday, September 1, occurred months after the negotiations took place between Swiss pharmaceutical company, Novartis and the NHS.
The announcement came after the results of the global trial, which was conducted by the Imperial College London, proved to be incredibly effective.
The Phase 3 trials demonstrated that when the inclisiran was administered 6 months apart, the medication managed to lower cholesterol levels by up to 50%.
The deal also represents a revolutionary approach to population health management, since it came about after the National Institute For Health and Care Excellence approval and the agreement by Novartis to lower the price of the medication.
Although the amount of the discount remains undisclosed at the moment, what is known is that Novartis usually prices their 284-milligram dose pack at around £2,000, or roughly $2700.
The Reason Inclisiran is Considered ‘Life Changing’
According to the manufacturer, inclisiran is the first treatment to use RNA interference that aids in removing harmful cholesterol from someone’s bloodstream.
How it works is by suppressing the PCSK9 gene, which is what tells the body ‘to produce a protein that helps regulate the amount of cholesterol in the blood.’ By blocking this gene, the medication helps allow the liver absorb more of the LDL cholesterol from that blood and aids in breaking it down.
Another positive point with inclisiran is that it could be a rather easy and effective option for those that haven’t had suitable reductions in their cholesterol levels with medications such as statins. It can also work for those that cannot take statins at all.
Moreover, when statins are combined with inclisiran, researchers foresee a 75% to 80% reduction in consumers’ cholesterol levels.
The jab, which is administered under-the-skin by a nurse, will be given twice per year. The NHS explains that momentarily, this new medication will be given to those that have suffered a heart attack or stroke, those who have high cholesterol, and those that have dyslipidemia – which is a genetic disorder that results in high cholesterol.
For those that require a prescription, they can get in touch with their general surgery without having to go to the hospital. According to a report in The Times, the drug could possibly be rolled out within the next month or so.
It Can Possibly Save Thousands of Lives
Should the plans to roll out the vaccines go as planned with an estimated 300,000 people receiving the medication from the NHS in the next three years, approximately 30,000 people could possibly avoid having a heart attack or a stroke.
The medical director of the British Heart Foundation (BHF), Professor Sir Nilesh Samani, shared, “The approval of inclisiran is good news for heart patients in the U.K. The twice-yearly injection to lower LDL, or ‘bad,’ cholesterol in patients with existing heart disease, whose cholesterol is not adequately controlled with statins or other drugs, will help to prevent people from having further heart attacks or strokes, ultimately maximizing the numbers of lives saved.”
Prof. Samani also said that it’s his hope that inclisiran will eventually be available for more of the population.
He said, “More research is needed to confirm the full extent of its benefits, but I anticipate that in the future, it will also be approved to lower cholesterol for a much wider group of people, to prevent them from having a heart attack or stroke in the first place.”
Director of the Imperial Centre for Cardiovascular Disease Prevention, Prof. Kausik Ray, shares that within the next 10 years, inclisiran should lessen the risk of heart attacks and strokes for people diagnosed with high cholesterol, as well as those with a history of heart disease from 29% to 20%.
He explains that the inclisiran and statins medications can work together, “Statins and inclisiran are complimentary. Statins make more cholesterol receptors, and inclisiran, by stopping the production of [the PCSK9 protein] makes these receptors last or survive longer. The two treatments reduce LDL [cholesterol] by about 75-80%, when compared to no treatment.”
Prof. Ray also adds that ‘a 50% annual reduction of LDL cholesterol in the population will translate to a 30% drop in cardiovascular events.’
Talking About Misconceptions About Inclisiran
A consultant interventional cardiologist at Birmingham City Hospital in the U.K., Dr. Derek Connolly, told Medical News Today that calling the drug “life changing” is completely accurate.
What the twice a year dosage also means is that it provides a simpler and more convenient type of treatment for patients. Moreover, Dr. Connolly shares that it’s “perfect for the statin-intolerant.” Although there is no long-term data about the drug at the moment, Dr. Connolly is not concerned about that.
He’s not the only one that thinks this way. Interventional cardiologist and associate professor of cardiology at Bahçeşehir University in Istanbul, Dr. Muhammed Keskin also agrees, “The fact that is provides very effective LDL reduction in patients with resistant high cholesterol will ensure that the drug is preferred. [I] do not think there is cause for concern because the side effect profile of the drug was found to be quite similar to [that of a] placebo.”
According to Dr. Keskin, he also said that inclisiran will also be quickly accepted because there is already a substantial amount of people with ‘resistant high LDL cholesterol.’ He explains, “These patients were already using a molecule called ezetimibe or two other [PCSK9] inhibitors. So inclisiran may be preferred over the other two PCSK9 inhibitors.”
Other medications that are used to inhibit PCSK9 in patients who cannot use statins or have high LDL levels despite using statins are evolocumab or alirocumab. These two medications are classified as monoclonal antibodies, which is a type of biological drug that is given in injection form every two weeks.
In addition, Dr. Keskin goes on to explain that although the new drug is also a PCSK9 inhibitor, it was developed using newer technology which is called ‘small interfering ribonucleic acid: siRNA.’
Dr. Connolly explain that one of the biggest challenges that inclisiran faces is to find people that are willing to try it, as well as healthcare professionals that are willing to prescribe it. He shared, “The problem is [that the] statin/vaccine denier community is already against this on principle. But if we can be as successful as the [COVID-19] vaccine rollout, we will save many lives.”
But Dr. Keskin points out that the studies they have done on the use of inclisiran so far have been limited. He told MNT, “The aim of the studies conducted was to treat patients who have high LDL despite using statins or those who cannot tolerate statins. Statins are still the first choice in cardiovascular diseases with high LDL cholesterol. The study did not include a population of patients who have never used statins.”
Dr. Keskin also shares that another hindrance is that rather high cost of the medication, which will also lead to limited access and use of the drug. While the European Commission was the first to approve of the use of inclisiran for lowering LDL cholesterol back in December 2020, the Food and Drug Administration (FDA) has yet to approve it.
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