A new daily pill – which slashes cholesterol levels far below what can be achieved with statins, according to clinical trials, and which is also affordable – has been approved by the US Food & Drug Administration and will be available soon, reports The New York Times.
The drug from Merck is much more effective at lowering cholesterol levels than statins, the cheap cholesterol-reducing pills, the company says. In clinical trials, it (brand name Lipfendra) showed it can cut levels of LDL – the dangerous cholesterol – to 50 or 60 or even lower. Adults not taking cholesterol-lowering drugs usually have levels above 100.
It works by inhibiting a protein known as PCSK9. New cholesterol guidelines issued by the American Heart Association and the American College of Cardiology say people with an above-average risk of heart attacks or strokes should get their LDL levels below 70.
Those at high risk because, for example, they have had a heart attack, should get their LDL below 55.
Lipfendra’s list price will be $315 for a 30-day supply, and it will be available in a few weeks, said Merck spokesperson Julie Cunningham.
Existing injectable drugs work in the same way but are more expensive, with list prices of $500 to $600 a month or more. Not all insurers pay, and some patients do not want injections.
Only 1% of the 6m eligible patients use the injected drugs. Yet a PCSK9 inhibitor can reduce the risk of heart attacks by 20% in high-risk patients.
Cardiologists not associated with Merck applauded the FDA approval and the drug’s price. The hope is that a pill that costs less than an injectable and is easier to take will allow many more patients to get their cholesterol levels under control.
“I’m thrilled,” said Dr Christopher Cannon, a cardiologist at Brigham and Women’s Hospital in Boston who consults for several drug companies, but not Merck.
“This would make a big difference compared with the cost of injectable PCSK9 inhibitors,” said Dr David Maron, a preventive cardiologist at Stanford.
In November, Merck reported results from a 24-week clinical trial of Lipfendra involving 2 912 people. The drug lowered LDL levels by up to 60%. And there was no difference in side effects between the drug and a placebo.
Those results are the same as what has been seen with the injectable drugs. In studies of the injectable drugs, blocking PCSK9 reduced the incidence of heart attacks, strokes and cardiovascular deaths by 20% in high-risk people.
Merck is conducting a study now to see if Lipfendra has the same effect, with Dr Dean Li, president of Merck Research Laboratories, saying he is confident that it will.
He said the company wants to make lowering cholesterol with Lipfendra as easy and convenient as it is with a statin. Primary care doctors can prescribe it – it does not have to be limited to cardiologists. And, he said, patients are used to taking daily pills. Most who are at risk for a heart attack already take at least a blood pressure pill, a statin and an aspirin. I
It’s not clear yet whether companies making injectable PCSK9 inhibitors will lower their prices to compete.
See more from MedicalBrief archives:
New pill shows significant cuts in cholesterol
LDL cholesterol levels must be lowered in high CVD risk patients
New, cheaper pill taken with statins lowers LDL cholesterol more