The FDA approves a new pill to lower cholesterol
The Food and Drug Administration on Thursday approved a daily pill that can lower cholesterol levels far below what can be achieved with statins, the cheap cholesterol-lowering pills.
The drug Enlicitide, whose brand name is Lipfendra, is manufactured by the pharmaceutical company Merck. Clinical studies have shown that it can reduce LDL levels – the dangerous type of cholesterol – to 50 or 60 or even lower. In adults who are not taking cholesterol-lowering medications, the levels are usually above 100. The effect is due to the inhibition of a protein called PCSK9.
New cholesterol guidelines from the American Heart Association and the American College of Cardiology say people who are at above-average risk of heart attacks or strokes should have their LDL levels below 70. People at high risk, for example because they have had a heart attack, should have their LDL level 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 medications that work in the same way but are more expensive, with list prices of $500 to $600 per month or more. Sometimes insurers are reluctant to pay, and some patients don’t want injections. Only 1 percent of the six million eligible patients take the injected drugs. Nevertheless, a PCSK9 inhibitor can reduce the risk of heart attack in high-risk patients by 20 percent.
Cardiologists not affiliated with Merck praised the drug’s FDA approval and price. The hope is that a pill that costs less than an injection 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 advises several pharmaceutical companies, but not Merck.
“This would make a big difference compared to the cost of injectable PCSK9 inhibitors,” said Dr. David Maron, preventative cardiologist at Stanford.
Last November, Merck reported results of a 24-week clinical trial of Lipfendra involving 2,912 people. The drug reduced LDL levels by up to 60 percent. And there was no difference in side effects between the drug and a placebo.
