The Food and Drug Administration approved a daily pill on Thursday that can lower cholesterol levels far below what can be achieved with statins, the cheap cholesterol-reducing pills.
The drug, enlicitide, whose brand name is Lipfendra, is made by the pharmaceutical company Merck. Clinical trials have shown that it can bring levels of LDL — the dangerous type of cholesterol — down 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 that people who have 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 a Merck spokeswoman, Julie Cunningham.
There are currently injectable drugs that work in the same way, but they are more expensive, with list prices of $500 to $600 a month or more. Insurers sometimes balk at paying, and some patients do not want injections. Only 1 percent of the six million eligible patients use the injected drugs. Yet a PCSK9 inhibitor can reduce the risk of heart attacks by 20 percent in high-risk patients.
Cardiologists not associated with Merck applauded the F.D.A. 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.
Last November, Merck reported results from a 24-week clinical trial of Lipfendra, which involved 2,912 people. The drug lowered LDL levels by up to 60 percent. 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 percent in high-risk people. Merck is conducting a study now to see if Lipfendra has the same effect. Dr. Dean Li, president of Merck Research Laboratories, said he is confident that it will.
Dr. Li 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.
It’s not clear yet whether companies making injectable PCSK9 inhibitors will lower their prices to compete.
