Amitabh Dube, country president and managing director, Novartis India, told ThePrint that the company had received the import and marketing permission for Inclisiran from the office of the Drug Controller General of India and is “gearing up to launch this innovative medicine this month”.
“Inclisiran has the potential to change the practice of medicine in treating atherosclerotic cardiovascular disease (ASCVD) patients,” Dube told ThePrint this week, but declined to reveal the cost of medicine in India.
Inclisiran, which is used for primary hypercholesterolaemia or mixed dyslipidemia, along with diet, has been available in the European Union since 2020, and in the US and the UK since 2021, under the brand name Leqvio.
The recommended dose is 284 mg, given as a single injection under the skin — first dose followed by another after three months and then every six months, said company sources.
India has been a site for the drug’s global clinical trials.
According to Dr Vaibhav Jain, associate consultant, cardiology, Fortis Memorial Research Institute, Gurugram, the potential market for Inclisiran in India may depend on several factors, such as the availability, affordability, and accessibility of the drug as well as awareness and acceptance of the new therapy among doctors and patients.
“It may also depend on the prevalence and severity of high cholesterol and cardiovascular disease in the population, and the comparison with other existing or emerging treatments,” said Jain.
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‘Need for a strong lipid-lowering treatment’
The most common forms of dyslipidemia in the country are borderline high LDL cholesterol, low HDL cholesterol and high triglycerides. High LDL-C or ‘bad’ cholesterol can lead to plaque buildup in the arteries, resulting in atherosclerotic cardiovascular diseases (ASCVD) such as coronary heart disease, angina (chest pain due to inadequate blood flow to the heart) and heart attacks.
For people with diabetes or heart disease, the optimal level of bad cholesterol is 100 mg/dL (milligrams per decilitre), while for others, the near-optimal level is 100 to 129 mg/dL and the borderline high level is 130 to 159 mg/dL. Anything above this level is considered high.
According to sources associated with Novartis, for every 38.7 mg/ dL increase in bad cholesterol, the risk of heart attack goes up by 30 percent and one in 10 patients had a second heart attack, a stroke, or a cardiovascular disease-related death within the first 100 days after the first attack.
They added that there is scientific proof that nearly 80 percent of the patients are not reaching the acceptable level of LDL-C after being on lipid-lowering therapies for one year following acute coronary syndrome (ACS), which includes conditions related to sudden, reduced blood flow to the heart.
“There is, therefore, a substantial unmet need for a strong lipid-lowering treatment in India,” one of the sources told ThePrint.
How does it differ from statins?
According to Dube, Inclisiran has been approved for use in combination with a statin (drugs that can lower your cholesterol) or other lipid-lowering therapies in patients who are unable to reach LDL-C goals with the maximum tolerated dose of a statin.
But patients who are statin-intolerant, or for whom a statin is not advised as a course of treatment, can take Inclisiran alone or with other lipid-lowering therapies, he added.
Statins are widely used pharmacotherapies for lowering cholesterol levels that work by inhibiting an enzyme called HMG-CoA reductase, which is involved in the synthesis of cholesterol in the liver.
Inclisiran, on the other hand, belongs to another class of medicines, known as gene-silencing drugs or small interfering ribonucleic acid (siRNA) therapies. This works by turning off, or ‘silencing’, the gene PCSK9, which in turn boosts the liver’s ability to remove harmful cholesterol from the blood.
The launch of Inclisiran comes six years after Hyderabad-based pharmaceutical major Dr Reddy’s Laboratories launched Evolocumab 140 mg/m — a monoclonal antibody under the brand name Repatha — the first PCSK9 Inhibitor in India.
Repatha is a patented product of Amgen, a US-based biotechnology company, and is also indicated for the treatment of adult patients with primary hypercholesterolaemia or mixed dyslipidemia.
Dr Reddy’s had tied up with Amgen for the marketing rights of the drug in India.
Repatha, costing about Rs 18,000 per injection, is also indicated for use by statin-intolerant patients or those with high bad cholesterol despite treatment with statin. It is to be administered as an injection every 15 days.
The main difference between Evolocumab and Inclisiran, according to the American Heart Association, is that while the former delivers antibodies to block the PCSK9 gene, the latter switches it off — meaning PCSK9 protein is not made in the liver, as a result of which more LDL receptors can return to the surface of the liver and continue to remove LDL cholesterol from the blood — thereby working for a longer period, nearly six months.
ThePrint reached Dr Reddy’s Laboratories over email and phone to understand its perspective on the response to Evolocumab in the Indian market but got no response. This copy will be updated if and when a reply is received.
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Cost likely to be a dampener
Dr Jain highlighted that statins are the most frequently prescribed drugs for lowering cholesterol, but they have some drawbacks and side effects.
“Statins can cause muscle pain, increased risk of diabetes, and liver problems in some people,” he said, adding that both Inclisiran and Evolocumab can be very effective in lowering LDL cholesterol levels, especially in people who have high cholesterol due to genetic factors or who cannot tolerate statins.
However, Inclisiran and Evolocumab are also more expensive than statins, and their long-term safety and effectiveness are still being studied, he added.
Dr Ambuj Roy, professor of cardiology at the All India Institute of Medical Sciences (AIIMS) in New Delhi, added that cost is the major limiting factor for the new lipid-lowering therapies.
“Their uptake even in the West has been below expectation, also there is a lack of long-term data for these medicines which are needed for a lifetime,” he told ThePrint, adding that as they are injectables, the fact adds to patient hesitancy.
(Edited by Richa Mishra)
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