A new cholesterol-lowering drug evolocumab has created quite a buzz in the past week.
A recently-concluded study has backed the drug in helping high-risk patients reduce the likelihood of a heart attack or stroke, but its high cost raises questions about how many patients will benefit, researchers said.
The first rigorous test of the expensive drug was conducted over two years and included men and women who had exhausted all other options.
The results of the clinical trial, which cost about $1 billion and was paid for by Amgen, the maker of the drug, were published in The New England Journal of Medicine and presented at a conference in United States.
Thinking of quickly getting your hands on the drug? Not just yet.
Who Can Get the Drug?
The drug is sold as Repatha by Amgen Phamaceuticals and costs more than USD 14,523 a year (approximately Rs 9.5 lakh).
While it was approved in US and the European Union in 2015, it hasn’t come to the Indian market. Amgen was looking to launch Repatha with the help of a waiver exempting the drug from pre-launch testing in Indian patients. But the Central Drugs Standard Control Organization (CDSCO) panel denied that request, delaying approval and entry in India.
It is not uncommon to provide this waiver in cases where the drug has been approved abroad. However, the drug should be marketed in other countries for a period of more than two years and adequate evidence regarding safety of the drug in published journals should be made available to CDSCO for the same.
Amgen then enlisted Indian pharmaceutical company Dr Reddy’s to speed up the process for Repatha’s entry into the market. When contacted by The Quint, Dr Reddy’s refused to comment on the status of bringing the drug here.
Abroad, the Repatha injection is only available with a doctor’s prescription and can’t be bought over-the-counter. It only caters to a certain subset of patients who are at high risk for cardiovascular events.
What the Study Found
The randomised trial involved 27,564 people who had experienced a prior heart attack or stroke, or who had significantly clogged arteries that limited blood flow to their limbs.
According to the study, evolocumab reduced low-density lipoprotein (LDL), or "bad" cholesterol, by 59 percent.
Clubbed with the existing statin therapy to reduce cholesterol levels, it also decreased the risk of heart attack or stroke or cardiovascular death by 15 percent in the first year and 25 percent in the second year.
"The drug was safe and well-tolerated," said lead study author Marc Sabatine.
The Quint spoke to cardiologists in India and based on the study many of them lauded the drug and said it’s definitely required in the country to cater to those in need of it.
I think it’s high time for the approving agency to reconsider their decision and bring the drug to India.Dr Amit Hooda, Consultant, Cardiology
But on the other hand, some were cautious and weren’t convinced of terming the drug ‘life-saving’. On the contrary, reports suggest that many are of the opinion that the study did not focus on the serious side effects, which could create neurological and behavioural problems.
Not Quite the End of Heart Disease
Experts not involved in the study described it as "exciting" and "major," but urged caution due to the high cost of the medication.
"This is very expensive stuff," said Valentin Fuster, a New York-based physician.
So the drug works, which is good news for patients. And no safety concerns emerged. But the applause from heart experts has been muted, because expectations were so much higher. Their hope had been that drastically low LDL cholesterol levels would make it difficult – or even impossible – to have a heart attack.
Fuster also noted that in absolute numbers, the drug saved about two percent of lives.
"We have to be very cautious in terms of the enthusiasm," he told reporters at the conference.
A report in The New York Times asks people to calm down and look at the picture more closely. In the report, a cardiologist at the University of California said she would like to see what happens to the death rates over a longer period of time.
The study’s short time frame also means that there wasn’t much time in which to detect safety problems. If you are cautious about the safety of medications, you may want to wait and see what happens as more people start using it.
The cardiologist also worried about the potential for bias because Amgen paid for the study, helped design it, collected the data and helped write the paper.
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